Drug Facts
4467666b-04cb-4cce-a300-871fc39d6df7
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredients (in each 5 mL tsp) Purpose Brompheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough Suppressant Phenylephrine HCl 2.5 mg Nasal Decongestant
Medication Information
Warnings and Precautions
Warnings
Do not use 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. Do not use on a child under 2 years of age.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- giving this product to children who are taking sedatives or tranquilizers
- if you are taking sedatives or tranquilizers
Indications and Usage
Other Information
- Store between 15-30 degrees C (59-89 degrees F)
- Tamper evident feature: Do not use if cap seal is broken or missing
Dosage and Administration
Directions Do not exceed more than 6 doses in any 24-hour period.
| adults and children 12 years of age and over |
take 1 teaspoonfuls (5 mL) every 4 hours |
| children 6 to under 12 years of age |
take 1/2 teaspoonfuls (2.5mL) every 4 hours |
| children 2 years to under 6 years of age |
ask a doctor |
| children under 2 years of age |
do not use |
Description
Active Ingredients (in each 5 mL tsp) Purpose Brompheniramine maleate 1 mg Antihistamine Dextromethorphan HBr 5 mg Cough Suppressant Phenylephrine HCl 2.5 mg Nasal Decongestant
Section 50565-1
Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Section 50570-1
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.
When using this product
- do not use more than directed
- may cause drowsiness
- avoid alcoholic drink
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- you get nervous, dizzy or sleeplessness
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Section 51727-6
Inactive Ingredients
Water, citric acid, methylparaben, glycerin, propylene glycol, propylparaben, sodium citrate, flavor, sucralose
Section 51945-4
Section 53413-1
Questions or comments: 1-305-403-3788
Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1
Uses
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
-
- sneezing
- itchy nose or throat
- runny nose
- itchy, water eyes
- nasal congestion
- temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
- temporarily restores freer breathing through nose
Section 55106-9
Brompheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough Suppressant
Phenylephrine HCl 2.5 mg Nasal Decongestant
Structured Label Content
Indications and Usage (34067-9)
Other Information
- Store between 15-30 degrees C (59-89 degrees F)
- Tamper evident feature: Do not use if cap seal is broken or missing
Dosage and Administration (34068-7)
Directions Do not exceed more than 6 doses in any 24-hour period.
| adults and children 12 years of age and over |
take 1 teaspoonfuls (5 mL) every 4 hours |
| children 6 to under 12 years of age |
take 1/2 teaspoonfuls (2.5mL) every 4 hours |
| children 2 years to under 6 years of age |
ask a doctor |
| children under 2 years of age |
do not use |
Warnings and Precautions (34071-1)
Warnings
Do not use 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. Do not use on a child under 2 years of age.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- giving this product to children who are taking sedatives or tranquilizers
- if you are taking sedatives or tranquilizers
Section 50565-1 (50565-1)
Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.
When using this product
- do not use more than directed
- may cause drowsiness
- avoid alcoholic drink
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- you get nervous, dizzy or sleeplessness
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Section 51727-6 (51727-6)
Inactive Ingredients
Water, citric acid, methylparaben, glycerin, propylene glycol, propylparaben, sodium citrate, flavor, sucralose
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments: 1-305-403-3788
Advanced Generic Corporation, Miami, Fl 33166
www.advancedgeneric.com
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1 (55105-1)
Uses
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
-
- sneezing
- itchy nose or throat
- runny nose
- itchy, water eyes
- nasal congestion
- temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
- temporarily restores freer breathing through nose
Section 55106-9 (55106-9)
Brompheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough Suppressant
Phenylephrine HCl 2.5 mg Nasal Decongestant
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:34.204140 · Updated: 2026-03-14T22:53:20.556394