Major Pharmaceuticals Children’s Dimaphen Dm Drug Facts

Major Pharmaceuticals Children’s Dimaphen Dm Drug Facts
SPL v6
SPL
SPL Set ID 67072a38-1ae7-4e59-bfed-71db0d93215d
Route
ORAL
Published
Effective Date 2020-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sorbitol

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2006-09-11 Until 2026-11-30

Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 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
  • 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

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.
  • to make a child sleepy
Other Information
  • each 10 mL contains: sodium 4 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

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

Questions Or Comments?

1-800-616-2471

Principal Display Panel

Children’s

Dimaphen DM

ANTIHISTAMINE, Brompheniramine Maleate

COUGH SUPPRESSANT, Dextromethorphan HBr

NASAL DECONGESTANT, Phenylephrine HCl

Relieves – Nasal Symptoms

Stuffy Nose – Runny Nose

Sneezing

Plus Other Symptoms

Itchy, Watery Eyes

Cough

GRAPE FLAVOR

Alcohol-Free

6 yrs. and older

COMPARE TO the active ingredients of DIMETAPP® COLD & COUGH

4 FL. OZ. (118 mL.)

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 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.
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 (1-800-222-1222).

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg

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 such as emphysema or chronic bronchitis
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

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
  • 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

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 an MAOI, ask a doctor or pharmacist before taking this product.
  • to make a child sleepy
Other Information (Other information)
  • each 10 mL contains: sodium 4 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-616-2471

Principal Display Panel

Children’s

Dimaphen DM

ANTIHISTAMINE, Brompheniramine Maleate

COUGH SUPPRESSANT, Dextromethorphan HBr

NASAL DECONGESTANT, Phenylephrine HCl

Relieves – Nasal Symptoms

Stuffy Nose – Runny Nose

Sneezing

Plus Other Symptoms

Itchy, Watery Eyes

Cough

GRAPE FLAVOR

Alcohol-Free

6 yrs. and older

COMPARE TO the active ingredients of DIMETAPP® COLD & COUGH

4 FL. OZ. (118 mL.)

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 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.
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 (1-800-222-1222).

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg

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 such as emphysema or chronic bronchitis
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
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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