Target Children’s Cold & Cough Drug Facts

Target Children’s Cold & Cough Drug Facts
SPL v5
SPL
SPL Set ID eb912834-1b14-484d-90f7-a8deb52c0d4e
Route
ORAL
Published
Effective Date 2024-07-04
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 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 2024-06-17

Description

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

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

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

Uses
  • temporarily relieves:
  • Nasal congestion
    • runny nose
    • cough
    • sneezing
    • itchy, watery eyes due to hay fever
    • 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
  • 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.
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

Questions Or Comments?

1-866-467-2748

Principal Display Panel

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

NDC 82442-645-04

Children's

Cold

& Cough

Brompheniramine maleate(Antihistamine)

Dextromethorphan HBr(Cough Suppressant)

Phenylephrine HCl(Nasal Decongestant)

Relieves + comforts

  • Stuffy, runny nose
  • Itchy, watery Eyes
  • Sneezing
  • Cough

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

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

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
  • nervousness, dizziness, or sleeplessness occurs
  • 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 at 1-800-222-1222.

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl, 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 or persistent 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 any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves:
  • Nasal congestion
    • runny nose
    • cough
    • sneezing
    • itchy, watery eyes due to hay fever
    • 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)
  • 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.
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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

NDC 82442-645-04

Children's

Cold

& Cough

Brompheniramine maleate(Antihistamine)

Dextromethorphan HBr(Cough Suppressant)

Phenylephrine HCl(Nasal Decongestant)

Relieves + comforts

  • Stuffy, runny nose
  • Itchy, watery Eyes
  • Sneezing
  • Cough

For Ages 6 Years and Over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

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

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)
  • nervousness, dizziness, or sleeplessness occurs
  • 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 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

Phenylephrine HCl, 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 or persistent 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 any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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