Version May 2024
Upper respiratory tract conditions: Oral: Note: These are general dosage guidelines; also refer to product specific dosing. All dosing is presented in terms of brompheniramine maleate and phenylephrine hydrochloride:
Liquid:
Brompheniramine 1 mg and phenylephrine 2.5 mg per 5 mL: 20 mL every 4 hours (maximum: 120 mL per 24 hours).
Brompheniramine 2 mg and phenylephrine 5 mg per 5 mL: 10 mL every 4 hours (maximum: 60 mL per 24 hours).
Brompheniramine 4 mg and phenylephrine 10 mg per 5 mL: 5 mL every 4 hours (maximum: 30 mL per 24 hours).
Tablets: Brompheniramine 4 mg and phenylephrine 10 mg per tablet: One tablet every 4 hours (maximum: 6 tablets 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Avoid use (Ref).
(For additional information see "Brompheniramine and phenylephrine: Pediatric drug information")
Note: Safety and efficacy for the use of cough and cold products in infants and young children is limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children; the FDA does not recommend OTC use in infants and children <2 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends to use with caution in pediatric patients ≥2 years of age (Ref). Multiple concentrations of oral liquid formulations exist; close attention must be paid to the concentration when ordering or administering.
Cough and upper respiratory allergy symptoms:
Liquid:
Brompheniramine 1 mg/phenylephrine 2.5 mg per 5 mL (eg, Dimetapp, Dimaphen, Rynex PE): Oral:
Children 6 to <12 years: 10 mL every 4 hours as needed; maximum daily dose: 60 mL/24 hours.
Children ≥12 years and Adolescents: 20 mL every 4 hours as needed; maximum daily dose: 120 mL/24 hours.
Brompheniramine 2 mg/phenylephrine 5 mg per 5 mL (eg, Maxi-Tuss PE): Oral:
Children 6 to <12 years: 5 mL every 4 hours as needed; maximum daily dose: 30 mL/24 hours.
Children ≥12 years and Adolescents: 10 mL every 4 hours as needed; maximum daily dose: 60 mL/24 hours.
Brompheniramine 4 mg and phenylephrine 10 mg per 5 mL (eg, Glenmax PEB): Oral:
Children ≥12 years and Adolescents: 5 mL every 4 hours; maximum daily dose: 30 mL/24 hours.
Tablets:
Brompheniramine 4 mg and phenylephrine 10 mg per tablet (eg, Ru-Hist D): Oral:
Children 6 to <12 years: 1/2 tablet every 4 hours as needed; maximum daily dose: 3 tablets/24 hours (6 doses).
Children ≥12 years and Adolescents: 1 tablet every 4 hours as needed; maximum daily dose: 6 tablets/24 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
See individual agents.
OTC labeling: When used for self-medication, do not use to sedate a child, or with or within 14 days of stopping monoamine oxidase inhibitor therapy.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
Special populations:
• Pediatric: Antihistamines may cause excitation in young children.
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 1997; CDC 1982); some data suggest 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:
• Self-medication (OTC use): When used for self-medication (OTC), notify health care provider prior to use if you have breathing problems (eg, chronic bronchitis, asthma, emphysema), diabetes, glaucoma, heart disease, high blood pressure, thyroid disease, difficultly in urination due to enlargement of the prostate gland, or are currently taking sedatives, tranquilizers, or other oral nasal decongestants or stimulants. Discontinue use and notify health care provider if new symptoms occur, symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache, or if nervousness, dizziness, or sleeplessness occur.
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). Antihistamines should not be used to make an infant or child sleepy. Multiple concentrations of oral liquid formulations exist; close attention must be paid to the concentration when ordering or administering.
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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, oral:
Dimaphen Children's: Brompheniramine maleate 1 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (118 mL [DSC]) [ethanol free, gluten free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; grape flavor]
Dimetapp Children’s Cold & Allergy: Brompheniramine maleate 2 mg and phenylephrine hydrochloride 5 mg per 10 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; grape flavor]
Glenmax PEB: Brompheniramine maleate 4 mg and phenylephrine hydrochloride 10 mg per 5 mL (473 mL) [alcohol free, dye free, sugar free; contains propylene glycol, saccharin sodium, sodium benzoate, sorbitol; fruit gum flavor]
Rynex PE: Brompheniramine maleate 1 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (473 mL) [ethanol free, gluten free, sugar free; contains propylene glycol; bubblegum flavor]
Generic: Brompheniramine maleate 2 mg and phenylephrine hydrochloride 5 mg per 5 mL (118 mL, 473 mL)
Tablet, oral:
Brohist D: Brompheniramine maleate 4 mg and phenylephrine hydrochloride 10 mg [DSC]
Ru-Hist D: Brompheniramine maleate 4 mg and phenylephrine hydrochloride 10 mg
Yes
Elixir (Dimetapp Cold/Allergy Oral)
1-2.5 mg/5 mL (per mL): $0.05
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.
Oral: Measure liquid doses using provided dosage cup only.
Oral: Administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur).
Upper respiratory tract conditions: Temporary relief of symptoms (nasal congestion, runny nose, sneezing, itchy nose or throat, itchy/watery eyes, nasal passages swelling) associated with the common cold, allergic rhinitis (hay fever), and other upper respiratory tract conditions.
Beers Criteria: Brompheniramine, a first-generation antihistamine, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potent anticholinergic properties resulting in increased risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity; use should also be avoided due to reduced clearance with advanced age and tolerance associated with use as a hypnotic. Exposure to concurrent anticholinergic drugs also increases risk of falls, delirium, and dementia; consider total anticholinergic burden when conducting medication reviews (Beers Criteria [AGS 2023]).
Refer to individual monographs.
Refer to individual monographs.
Some products contain sodium.
See individual monograph for Phenylephrine.
Brompheniramine component only:
Distribution: Vd: Mean: Children 6 to 12 years: 20 L/kg (Simons 1999); Adults: 11.7 L/kg (Simons 1982)
Protein binding: 39% to 49% (Martínez-Gómez 2007)
Metabolism: Hepatic, extensive (Simons 2004)
Half-life elimination: Mean: Children 6 to 12 years: 12.4 hours (Simons 1999); Adults: 24.9 hours (Simons 1982)
Time to peak, serum: Oral: Children 6 to 12 years: 3.2 hours (Simons 1999); Adults: 2 to 4 hours (Simons 1982)
Excretion: Urine (50%, as inactive metabolites) (Bruce 1968)
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