Childrens Robitussin Cough Long-acting Liquid
FDA Label NDC 0031-8694

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Childrens Robitussin Cough Long-acting (NDC 0031-8694). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 10 ml), purpose, use, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 10 Ml)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Use

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have

  • 1.cough that occurs with too much phlegm (mucus)
  • 2.cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Directions

  • 1.measure only with dosing cup provided
  • 2.keep dosing cup with product
  • 3.ml = milliliter
  • 4.do not take more than 4 doses in any 24-hour period
    • agedose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 ml every 6 - 8 hours

    children 6 to
    under 12 years

    10 ml
    every 6 to 8 hours

    adults and children
    12 years and older

    20 ml
    every 6 to 8 hours

Other Information

  • 1.each 10 ml contains: sodium 11 mg
  • 2.store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate

Questions Or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by:
Pfizer, Madison, NJ 07940 USA

For most recent product information, visit
www.robitussin.com

Principal Display Panel

NEW
Dosing
Information

Children's
Robitussin®
NOW FOR AGES 4 & OVER

Cough

Long-Acting

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves:

✓ Cough Up to 8 Hours

Alcohol-Free

fruit
punch
flavor

4 FL OZ
(118 ml)

Principal Display Panel (118 ml Bottle Carton)

Principal Display Panel (118 ml Bottle Carton)

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