Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ec652577-df54-41fb-a9ee-bdc0f2e17d07
Route
ORAL
Published
Effective Date 2018-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sorbitol Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH FINAL Active Since 1999-03-16

Description

Brompheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 5 mg Phenylephrine HCl , USP 2.5 mg

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Brompheniramine maleate, USP 1 mg Dextromethorphan HBr, USP 5 mg Phenylephrine HCl , USP 2.5 mg

Uses
  • 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
Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
age dose
adults and children 12 years and over 4 tsp every 4 hours
children 6 to under 12 years 2 tsp every 4 hours
children under 6 years ask a doctor
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 MAOI, ask a doctor or pharmacist before taking this product.
Other Information
  • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
  • each teaspoon (5 ml) contains: sodium 5 mg
  • store at room temperature 15º - 30ºC (59º - 86ºF)
Inactive Ingredients

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water

Principal Display Panel

When Using This Product
  • 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
Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • 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.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • 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 or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each 5ml Tsp)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl , USP 2.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

Structured Label Content

Uses (USES)
  • 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
Purposes (PURPOSES)

Antihistamine

Cough suppressant

Nasal decongestant

Directions (DIRECTIONS)
  • do not take more than 6 doses in any 24-hour period
age dose
adults and children 12 years and over 4 tsp every 4 hours
children 6 to under 12 years 2 tsp every 4 hours
children under 6 years ask a doctor
Do Not Use (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 MAOI, ask a doctor or pharmacist before taking this product.
Other Information
  • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
  • each teaspoon (5 ml) contains: sodium 5 mg
  • store at room temperature 15º - 30ºC (59º - 86ºF)
Inactive Ingredients (INACTIVE INGREDIENTS)

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • 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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • 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 or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Active Ingredients (in Each 5ml Tsp) (Active Ingredients (in each 5mL tsp))

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl , USP 2.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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