major pharmaceuticals children’s dimaphen dm drug facts

major pharmaceuticals children’s dimaphen dm drug facts
SPL v1
SPL
SPL Set ID da148c1d-e394-4367-83e0-533469501b30
Route
oral
Published
Effective Date 2025-03-27
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 active Since 2025-03-27

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

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


Medication Information

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
Purpose

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

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

Description

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

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.)

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8134-1

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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
Questions Or Comments?

1-800-616-2471

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
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

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

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.)

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-8134-1

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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
Questions Or Comments? (Questions or comments?)

1-800-616-2471

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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