target children’s cold & cough drug facts

target children’s cold & cough drug facts
SPL v2
SPL
SPL Set ID bfc91c71-0506-4e94-8bfe-dc9e4bf959da
Route
oral
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
brompheniramine (2 mg) dextromethorphan (10 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol propyl gallate water sodium benzoate sodium citrate, unspecified form sorbitol sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2025-05-16

Purpose

Antihistamine Cough suppressant

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg


Medication Information

Uses
  • temporarily relieves:
    • runny nose
    • cough
    • sneezing
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • itching of the nose or throat
  • temporarily alleviates the intensity of coughing
Purpose

Antihistamine Cough suppressant

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 6 mg
  • store at room temperature.
Inactive Ingredients

citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg

Principal Display Panel

Compare to the active ingredients in Children’s Dimetapp® Cold & Cough*

NDC 82442-654-04

Children's

Cold

& Cough

Brompheniramine maleate(Antihistamine)

Dextromethorphan HBr(Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery Eyes
  • Sneezing
  • Cough

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

IMPORTANT: Keep this carton for future reference on full labelling.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Cough.

Purposes

Antihistamine

Cough suppressant

Do Not Use
  • to sedate a child or to make a child sleepy
  • 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.
Questions Or Comments?

1-866-467-2748

When Using This Product
  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • 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
  • 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 at 1-800-222-1222.

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves:
    • runny nose
    • cough
    • sneezing
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • itching of the nose or throat
  • temporarily alleviates the intensity of coughing
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 6 mg
  • store at room temperature.
Inactive Ingredients (Inactive ingredients)

citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients in Children’s Dimetapp® Cold & Cough*

NDC 82442-654-04

Children's

Cold

& Cough

Brompheniramine maleate(Antihistamine)

Dextromethorphan HBr(Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery Eyes
  • Sneezing
  • Cough

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

8 FL OZ (236 ml)

IMPORTANT: Keep this carton for future reference on full labelling.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING.

Distributed by:

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Cough.

Purposes

Antihistamine

Cough suppressant

Do Not Use (Do not use)
  • to sedate a child or to make a child sleepy
  • 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.
Questions Or Comments? (Questions or comments?)

1-866-467-2748

When Using This Product (When using this product)
  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • 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)
  • 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 at 1-800-222-1222.

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

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, 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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