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

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

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


Medication Information

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
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 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 Phenylephrine HCl, 5 mg

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*.

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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 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
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 82442-645-04

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*.

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

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 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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