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8cea1101-e91e-41ab-9fb5-da6ab61ea34f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg
Medication Information
Indications and Usage
• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves these symptoms due to hay fever (allergic rhinitis): • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily restores freer breathing through the nose
Dosage and Administration
• do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
Description
Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg
Section 44425-7
• each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)
Section 50565-1
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Section 50566-9
• you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7
• do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
Section 50568-5
taking sedatives or tranquilizers
Section 50569-3
• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy
Section 51727-6
anhydrous citric acid, edetate disodium, FD & C blue no. 1, FD & C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Section 51945-4
For Ages 6 & Older Compare to Children’s Dimetapp ® Cold & Cough active ingredients Children’s Cold & Cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms Stuffy Nose, Runny Nose, Sneezing Plus Other Symptoms Itchy, Watery Eyes; Cough Alcohol-Free Grape Flavor Dosage Cup Included 8 FL OZ (237 mL)
Section 53413-1
1-800-719-9260
Section 53414-9
ask a health professional before use.
Section 55105-1
Antihistamine Cough suppressant Nasal decongestant
Section 55106-9
Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg
Structured Label Content
Indications and Usage (34067-9)
• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves these symptoms due to hay fever (allergic rhinitis): • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat • temporarily restores freer breathing through the nose
Dosage and Administration (34068-7)
• do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
Section 44425-7 (44425-7)
• each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)
Section 50565-1 (50565-1)
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Section 50566-9 (50566-9)
• you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Section 50567-7 (50567-7)
• do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
Section 50568-5 (50568-5)
taking sedatives or tranquilizers
Section 50569-3 (50569-3)
• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Section 50570-1 (50570-1)
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • to make a child sleepy
Section 51727-6 (51727-6)
anhydrous citric acid, edetate disodium, FD & C blue no. 1, FD & C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Section 51945-4 (51945-4)
For Ages 6 & Older Compare to Children’s Dimetapp ® Cold & Cough active ingredients Children’s Cold & Cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms Stuffy Nose, Runny Nose, Sneezing Plus Other Symptoms Itchy, Watery Eyes; Cough Alcohol-Free Grape Flavor Dosage Cup Included 8 FL OZ (237 mL)
Section 53413-1 (53413-1)
1-800-719-9260
Section 53414-9 (53414-9)
ask a health professional before use.
Section 55105-1 (55105-1)
Antihistamine Cough suppressant Nasal decongestant
Section 55106-9 (55106-9)
Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:26.827104 · Updated: 2026-02-15T12:04:26.670552