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Acetaminophen, guaifenesin, and phenylephrine: Drug information

Acetaminophen, guaifenesin, and phenylephrine: Drug information
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Brand Names: US
  • FT Sinus Severe [OTC];
  • GoodSense Cold & Head Congest [OTC];
  • GoodSense Pressure/Pain/Mucus [OTC] [DSC];
  • GoodSense Sinus Severe Daytime [OTC];
  • Mucinex Fast-Max Congest/HA MS [OTC] [DSC];
  • Mucinex Fast-Max [OTC] [DSC];
  • Mucinex Freefrom Cld/Flu/Cngst [OTC] [DSC];
  • Mucinex Sinus-Max Cong & Pain [OTC];
  • Mucinex Sinus-Max Congestion [OTC] [DSC];
  • Mucinex Sinus-Max Sev Cong/Pn [OTC];
  • Mucinex Sinus-Max [OTC];
  • Sudafed PE Head Congestion [OTC];
  • Tylenol Cold & Head [OTC];
  • Tylenol Sinus Severe [OTC]
Pharmacologic Category
  • Alpha-Adrenergic Agonist;
  • Analgesic, Nonopioid;
  • Decongestant;
  • Expectorant
Dosing: Adult

Note: When calculating the maximum daily dose, consider all sources of acetaminophen (prescription and OTC) and all routes of administration. Do not exceed the maximum recommended daily dose.

Allergies/common cold/hay fever

Allergies/common cold/hay fever: Oral:

Acetaminophen 325 mg/guaifenesin 200 mg/phenylephrine 5 mg: Two tablets every 4 hours. Refer to product-specific labeling for maximum daily dosage; varies by product (maximum dosage range: 10 to 12 tablets [acetaminophen 3,250 to 3,900 mg/guaifenesin 2,000 to 2,400 mg/phenylephrine 50 to 60 mg] per 24 hours).

Acetaminophen 650 mg/guaifenesin 400 mg/phenylephrine 10 mg per 20 mL: 20 mL every 4 hours (maximum: 120 mL [acetaminophen 3,900 mg/guaifenesin 2,400 mg/phenylephrine 60 mg] per 24 hours).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use caution in patients with hepatic impairment or active liver disease.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Acetaminophen, guaifenesin, and phenylephrine: Pediatric drug information")

Allergies/common cold/hay fever

Allergies/common cold/hay fever: Note: When calculating the maximum daily dose, consider all sources of acetaminophen (prescription and OTC) and all routes of administration. Do not exceed the maximum recommended daily dose.

Tablet: Acetaminophen 325 mg/guaifenesin 200 mg/phenylephrine 5 mg per tablet (eg, Sudafed PE Head Congestion + Mucus, Tylenol Cold & Head, Tylenol Sinus Severe): Children ≥12 years and Adolescents: Oral: 2 tablets every 4 hours as needed; maximum daily dose: 10 tablets per 24 hours.

Oral liquid: Acetaminophen 650 mg/guaifenesin 400 mg/phenylephrine 10 mg per 20 mL (eg, Mucinex Sinus-Max Severe Congestion & Pain): Children ≥12 years and Adolescents: Oral: 20 mL every 4 hours as needed; maximum daily dose: 120 mL (6 doses) per 24 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at recommended daily acetaminophen dosages have been reported. Avoid chronic use in hepatic impairment. Also see Acetaminophen monograph.

Adverse Reactions

See individual agents.

Contraindications

OTC labeling: When used for self-medication, do not use with any other drug containing acetaminophen; in combination with or within 14 days of stopping a monoamine oxidase inhibitor (MAOI); if you are hypersensitive to acetaminophen, guaifenesin, phenylephrine, or any component of the formulation.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Acetaminophen has been associated with acute liver failure, at times resulting in liver transplant and death. Hepatotoxicity is usually associated with excessive acetaminophen intake and often involves more than one product that contains acetaminophen. Do not exceed the maximum recommended daily dose (>4 g daily). In addition, chronic daily dosing may also result in liver damage in some patients.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

• Skin reactions: Serious and potentially fatal skin reactions, including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have occurred rarely with acetaminophen use. Discontinue therapy at the first appearance of skin rash, skin reddening, or blisters.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).

• Diabetes: Use with caution in patients with diabetes mellitus.

• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage. Avoid ethanol or limit to <3 alcoholic drinks/day.

• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease.

• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Special populations:

• Older adult: Use with caution in the elderly; more likely to experience adverse reactions to sympathomimetics.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Dosage limit: Limit acetaminophen dose to <4 g/day.

• Self-medication (OTC use): When used for self-medication (OTC), patients with persistent or chronic cough (associated with COPD, asthma or smoking) and/or productive cough (eg, copious amounts of phlegm) should be evaluated by a healthcare provider prior to use. Discontinue use and notify healthcare provider if pain, cough, or nasal congestion gets worse or lasts >7 days; fever gets worse or lasts >3 days; cough comes back or occurs with rash or headache that lasts; if any new symptoms or nervousness, dizziness, or sleeplessness occur; or if redness or swelling is present.

Warnings: Additional Pediatric Considerations

Hepatoxicity has been reported in patients using acetaminophen. In pediatric patients, this is most commonly associated with supratherapeutic dosing, more frequent administration than recommended, and use of multiple acetaminophen-containing products; however, hepatotoxicity has been rarely reported with recommended dosages (AAP [Sullivan 2011]; Heard 2014). All sources of acetaminophen (eg, prescription, OTC, combination) should be considered when evaluating a patient's maximum daily dose. To lower the risk for hepatotoxicity, the maximum daily acetaminophen dose should be limited to ≤75 mg/kg/day (maximum of 5 daily doses), not to exceed 4,000 mg/day (AAP [Sullivan 2011]; Heard 2014; Krenzelok 2012; Lavonas 2010). Acetaminophen avoidance or a lower total daily dose (2,000 to 3,000 mg/day) has been suggested for adults with increased risk for acetaminophen hepatotoxicity (eg, malnutrition, certain liver diseases, use of drugs that interact with acetaminophen metabolism); similar data are unavailable in pediatric patients (Hayward 2016; Larson 2007; Worriax 2007).

Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported (in some cases, high blood concentrations of pseudoephedrine were found). Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Liquid, Oral:

Mucinex Fast-Max: Acetaminophen 650 mg, guaifenesin 400 mg, and phenylephrine hydrochloride 10 mg per 20 mL (180 mL [DSC]) [contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]

Mucinex Freefrom Cld/Flu/Cngst: Acetaminophen 650 mg, guaifenesin 400 mg, and phenylephrine hydrochloride 10 mg per 20 mL (180 mL [DSC]) [alcohol free, no artificial color(s), no artificial flavor(s), sugar free; contains carmine (cochineal extract), edetate (edta) disodium, glycerin (soy), propylene glycol, sodium benzoate]

Mucinex Sinus-Max: Acetaminophen 650 mg, guaifenesin 400 mg, and phenylephrine hydrochloride 10 mg per 20 mL (180 mL [DSC]) [contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate]

Mucinex Sinus-Max Cong & Pain: Acetaminophen 650 mg, guaifenesin 400 mg, and phenylephrine hydrochloride 10 mg per 20 mL (180 mL) [contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; fruit flavor]

Mucinex Sinus-Max Congestion: Acetaminophen 650 mg, guaifenesin 400 mg, and phenylephrine hydrochloride 10 mg per 20 mL (180 mL [DSC]) [contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), propylene glycol, quinoline yellow (d&c yellow #10), sodium benzoate; menthol flavor]

Tablet, Oral:

FT Sinus Severe: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [contains corn starch]

FT Sinus Severe: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [contains corn starch; mint flavor]

GoodSense Cold & Head Congest: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg

GoodSense Pressure/Pain/Mucus: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [DSC]

GoodSense Sinus Severe Daytime: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg

Mucinex Fast-Max Congest/HA MS: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Mucinex Sinus-Max: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Mucinex Sinus-Max Congestion: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Mucinex Sinus-Max Sev Cong/Pn: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Sudafed PE Head Congestion: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg

Tylenol Cold & Head: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg

Tylenol Sinus Severe: Acetaminophen 325 mg, guaifenesin 200 mg, and phenylephrine hydrochloride 5 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Liquid (Mucinex Sinus-Max Cong & Pain Oral)

10-650-400 mg/20 mL (per mL): $0.07

Tablets (Mucinex Sinus-Max Oral)

5-325-200 mg (per each): $0.74

Tablets (Mucinex Sinus-Max Sev Cong/Pn Oral)

5-325-200 mg (per each): $0.70

Tablets (Sudafed PE Head Congestion Oral)

5-325-200 mg (per each): $0.29

Tablets (Tylenol Cold & Head Oral)

5-325-200 mg (per each): $0.29

Tablets (Tylenol Sinus Severe Oral)

5-325-200 mg (per each): $0.30

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral:

Liquid: Only use enclosed dosing cup; do not use other devices.

Tablets: Swallow whole; do not crush, chew, or dissolve.

Administration: Pediatric

Oral: Administer without regard to meals; if GI distress, may administer with food.

Liquid: Only use enclosed dosing cup; do not use other devices.

Tablets: Swallow whole; do not crush, chew, or dissolve.

Use: Labeled Indications

Allergies/common cold/hay fever: Temporary relief of symptoms (eg, headache, minor aches/pains, nasal congestion, sinus congestion/pressure) associated with hay fever, other respiratory allergies, or the common cold; temporarily reduces fever; helps loosen phlegm and thin bronchial secretions.

Medication Safety Issues
Other safety concerns:

Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alcohol (Ethyl): May increase hepatotoxic effects of Acetaminophen. Risk C: Monitor

Alpha1-Blockers: May decrease vasoconstricting effects of Phenylephrine (Systemic). Risk C: Monitor

Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Atropine (Systemic): May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Belumosudil: May increase serum concentration of UGT1A1 Substrates. Management: Avoid coadministration of belumosudil with substrates of UGT1A1 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the UGT1A1 substrate may be required. Risk D: Consider Therapy Modification

Benzylpenicilloyl Polylysine: Coadministration of Alpha1-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Consider delaying skin testing until alpha1-agonists are no longer required, or use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider Therapy Modification

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification

Busulfan: Acetaminophen may increase serum concentration of Busulfan. Risk C: Monitor

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

CarBAMazepine: May increase metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor

Chloroprocaine (Systemic): May increase hypotensive effects of Phenylephrine (Systemic). Risk C: Monitor

CloZAPine: May decrease therapeutic effects of Phenylephrine (Systemic). Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

Dapsone (Topical): May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Risk C: Monitor

Dasatinib: Acetaminophen may increase hepatotoxic effects of Dasatinib. Dasatinib may increase serum concentration of Acetaminophen. Management: Avoid coadministration of acetaminophen and dasatinib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider Therapy Modification

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Disulfiram: May increase adverse/toxic effects of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha1-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

FentaNYL: Decongestants may decrease serum concentration of FentaNYL. Risk C: Monitor

Flucloxacillin: May increase adverse/toxic effects of Acetaminophen. Specifically, the risk for high anion gap metabolic acidosis may be increased. Risk C: Monitor

Fosphenytoin-Phenytoin: May decrease serum concentration of Acetaminophen. Specifically, serum concentrations of acetaminophen may be decreased (leading to decreased efficacy), but the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite may be increased (leading to increased hepatotoxicity). Risk C: Monitor

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Hyaluronidase: May increase vasoconstricting effects of Phenylephrine (Systemic). Management: Do not use hyaluronidase to enhance the dispersion or absorption of phenylephrine. Use of hyaluronidase for other purposes in patients receiving phenylephrine may be considered as clinically indicated. Risk D: Consider Therapy Modification

Imatinib: Acetaminophen may increase hepatotoxic effects of Imatinib. Risk C: Monitor

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Acetaminophen may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid

Isoniazid: May increase hepatotoxic effects of Acetaminophen. Isoniazid may increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

LamoTRIgine: Acetaminophen may decrease serum concentration of LamoTRIgine. Risk C: Monitor

Landiolol: Sympathomimetics may decrease therapeutic effects of Landiolol. Risk C: Monitor

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Lisuride: May increase hypertensive effects of Alpha1-Agonists. Risk X: Avoid

Local Anesthetics: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor

Lorlatinib: May decrease serum concentration of Acetaminophen. Risk C: Monitor

Melperone: May decrease therapeutic effects of Phenylephrine (Systemic). Risk C: Monitor

Metergoline: May increase adverse/toxic effects of Alpha1-Agonists. Risk C: Monitor

Methotrimeprazine: May increase CNS depressant effects of Products Containing Ethanol. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid

MetroNIDAZOLE (Systemic): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk X: Avoid

MetroNIDAZOLE (Topical): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk C: Monitor

MetyraPONE: May increase serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk X: Avoid

Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor

Monoamine Oxidase Inhibitors: May increase hypertensive effects of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid

Nitric Oxide: May increase adverse/toxic effects of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

Pergolide: May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

PHENobarbital: May increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

Prilocaine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor for signs of methemoglobinemia when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid use of these agents with prilocaine/lidocaine cream in infants less than 12 months of age. Risk C: Monitor

Primaquine: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Primaquine. Specifically, the risk for methemoglobinemia may be increased. Management: Avoid concomitant use of primaquine and other drugs that are associated with methemoglobinemia when possible. If combined, monitor methemoglobin levels closely. Risk D: Consider Therapy Modification

Primidone: May increase metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor

Probenecid: May increase serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Management: Consider limiting acetaminophen use in combination with probenecid. Probenecid may reduce clearance of acetaminophen to one of its non-toxic metabolities, increasing the risk for acetaminophen toxicity, even a lower doses. Risk D: Consider Therapy Modification

Propacetamol: May increase serum concentration of Phenylephrine (Systemic). Management: Monitor patients closely for increased side effects of phenylephrine if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Risk C: Monitor

RifAMPin: May increase hepatotoxic effects of Acetaminophen. RifAMPin may decrease serum concentration of Acetaminophen. Risk C: Monitor

Secnidazole: Products Containing Ethanol may increase adverse/toxic effects of Secnidazole. Risk X: Avoid

Sodium Nitrite: Methemoglobinemia Associated Agents may increase adverse/toxic effects of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

SORAfenib: Acetaminophen may increase hepatotoxic effects of SORAfenib. SORAfenib may increase serum concentration of Acetaminophen. Management: Avoid coadministration of acetaminophen and sorafenib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider Therapy Modification

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tricyclic Antidepressants: May increase therapeutic effects of Alpha1-Agonists. Tricyclic Antidepressants may decrease therapeutic effects of Alpha1-Agonists. Risk C: Monitor

Vaccines: Acetaminophen may decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification

Vitamin K Antagonists: Acetaminophen may increase anticoagulant effects of Vitamin K Antagonists. This appears most likely with daily acetaminophen doses exceeding 1.3 or 2 g/day for multiple consecutive days. Risk C: Monitor

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Dietary Considerations

Some products may contain sodium.

Mechanism of Action

Acetaminophen: Although not fully elucidated, the analgesic effects are believed to be due to activation of descending serotonergic inhibitory pathways in the CNS. Interactions with other nociceptive systems may be involved as well (Smith 2009). Antipyresis is produced from inhibition of the hypothalamic heat-regulating center.

Guaifenesin: Acts as an expectorant by increasing the effective hydration of the respiratory tract, maintains the sol layer needed for ciliary clearance and reduces the viscosity of respiratory mucus.

Phenylephrine: Causes vasoconstriction of the arterioles of the nasal mucosa.

Pharmacokinetics (Adult Data Unless Noted)

Refer to individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Panadol cold & flu all in one;
  • (AR) Argentina: Next cb rapida accion | Tabcin plus rapida accion;
  • (AT) Austria: Influbene;
  • (AU) Australia: Codral cold & flu + mucus cough | Codral relief 6 signs cold & flu | Lemsip cough max for mucus cough & cold | Lemsip max multi symptom relief | Lemsip multi symptom relief;
  • (BG) Bulgaria: Coldrex | Coldrex Junior | Coldrex max plus cough | Ferveflu antitussive | Flurapid max | Gripofen antitussive | Theraflu Forte | Theraflu max cold and cough;
  • (CZ) Czech Republic: Theraflu Forte | Vicks symptomed complete;
  • (DE) Germany: Lemsip cough max for mucus cough & cold | Wick Daymed Kombi;
  • (EC) Ecuador: Comtrex antigripal dia;
  • (EE) Estonia: Coldrex hotex | Theraflu;
  • (EG) Egypt: Expectoflu | Guamusin | Stopadol col & flu | Tristreanght | Xecamcold;
  • (ES) Spain: Bronchogrip | Gripavicks;
  • (GB) United Kingdom: Asda flu max all in one chesty cough & cold | Beechams All In One | Beechams all-in-one | Beechams max strength all in one | Benylin chesty cough & cold | Benylin mucus cough & cold all in one relief | BOOTS ULTRA COLD AND FLU RELIEF | Cold and flu nurse | Flu max all in one | Galpharm flu max all in one chesty cough & cold | Lemsip cough max for chesty cough & cold | Lemsip Max All In One | Olbas max strength all in one | Sudafed mucus relief triple action cold & flu | Tesco max strength all in one cold & flu relief | Ultra cold & flu relief all in one;
  • (GR) Greece: Panadol cold & flu & cough;
  • (HK) Hong Kong: Coltalin cough hot remedy | Panadol cold & cough;
  • (HR) Croatia: Theraflu | Theraflu max;
  • (HU) Hungary: Coldrex plus | Neo citran cold and cough | Neo citran max | Rubophen thermoplus | Wick Triactin;
  • (ID) Indonesia: Pim tra kol kids;
  • (IE) Ireland: Benylin phlegm | Lemsip multi relief | Perrigo cold & flu | Perrigo cold & flu multi relief | Solpa cold & flu multi relief | Solpa cold & flu multi relief max;
  • (IT) Italy: Nirolex flu tripla azione | Vicks flu tripla azione;
  • (KW) Kuwait: Panadol cold & flu all in one;
  • (LT) Lithuania: Triflunex;
  • (LV) Latvia: Theraflu | Triflunex;
  • (NG) Nigeria: Avrolin cough & cold;
  • (NZ) New Zealand: Codral cold & flu +mucus cough | Codral relief 6 signs cold & flu | Codral Relief Max Strength 6 Signs;
  • (PE) Peru: Comtrex antigripal dia | Fulgrip plus antigripal | Ressfril dia | Tapsin flu caliente;
  • (PL) Poland: Coldrex complex grip | Coldrex muco grip | Theraflu Total Grip | Vicks symptomed complete;
  • (PR) Puerto Rico: Coldonyl | Duratuss a | Mucinex fast max cold & sinus | Mucinex fast max cold and sinus | Sine off severe cold | Sinex severe congestion | Sudafed pe head congestion + mucus | Tylenol sinus congestion & pain severe;
  • (PT) Portugal: Antigrippine trieffect tosse | Panadol gripus;
  • (QA) Qatar: Panadol Cold and Flu All in One;
  • (RO) Romania: Coldrex Junior | Coldrex raceala si tuse | Revigrip hot lemon | Revigrip hot lemon max | Theraflu raceala si tuse;
  • (RU) Russian Federation: Vicks antigrip complex;
  • (SI) Slovenia: Combocoldrex;
  • (SK) Slovakia: Coldrex Grip plus kasel | Coldrex Junior | Theraflu;
  • (UA) Ukraine: Aksagripp
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