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Acetaminophen, guaifenesin, and phenylephrine: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • FT Sinus Severe [OTC];
  • GoodSense Cold & Head Congest [OTC];
  • GoodSense Pressure/Pain/Mucus [OTC];
  • 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] [DSC];
  • 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: Hepatic 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: Hepatic 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, 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; 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

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 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 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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May increase the serum concentration of Phenylephrine (Systemic). Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the hepatotoxic effect of Acetaminophen. Risk C: Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atropine (Systemic): May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

Benzylpenicilloyl Polylysine: Alpha1-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. 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

Bromocriptine: May enhance the hypertensive effect 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 the serum concentration of Busulfan. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

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

Chloroprocaine (Systemic): May enhance the hypotensive effect of Phenylephrine (Systemic). Risk C: Monitor therapy

CloZAPine: May diminish the therapeutic effect of Phenylephrine (Systemic). Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect 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 enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the 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

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

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha1-Agonists. Risk X: Avoid combination

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

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

Fosphenytoin-Phenytoin: May decrease the 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 therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Hyaluronidase: May enhance the vasoconstricting effect 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 enhance the hepatotoxic effect of Imatinib. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Acetaminophen may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect 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 combination

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

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

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

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

Linezolid: May enhance the hypertensive effect 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 enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination

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

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

Methotrimeprazine: Products Containing Ethanol may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, a disulfiram-like reaction may occur and CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination

MetyraPONE: May increase the 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 combination

Mipomersen: Acetaminophen may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy

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

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect 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 combination

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

Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

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

Phenylephrine (Systemic): Acetaminophen may increase the serum concentration of Phenylephrine (Systemic). Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

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

Probenecid: May increase the 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 the 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 therapy

RifAMPin: May enhance the hepatotoxic effect of Acetaminophen. RifAMPin may decrease the serum concentration of Acetaminophen. Risk C: Monitor therapy

Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination

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

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the 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 enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Risk C: Monitor therapy

Vaccines: Acetaminophen may diminish the therapeutic effect 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 (eg, warfarin): Acetaminophen may enhance the anticoagulant effect 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 therapy

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: 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;
  • (EE) Estonia: Coldrex hotex | Theraflu;
  • (EG) Egypt: Expectoflu | Guamusin | Stopadol col & flu | Tristreanght;
  • (ES) Spain: Bronchogrip | Gripavicks;
  • (GB) United Kingdom: Asda flu max all in one chesty cough & cold | Beechams All In One | Beechams all-in-one | Benylin chesty cough & cold | Benylin mucus cough & cold all in one relief | BOOTS ULTRA COLD AND FLU RELIEF | Flu max all in one | Galpharm flu max all in one chesty cough & cold | Lemsip Max All In One | Olbas max strength all in one | Sudafed mucus relief triple action cold & flu | 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;
  • (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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Topic 109301 Version 221.0

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