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Distributed by:
Pfizer, Madison, NJ 07940 USA
Childrens Robitussin Cough And Chest Congestion Dm Liquid
FDA Label NDC 0031-8715
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 And Chest Congestion Dm (NDC 0031-8715). 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 other, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 ml) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Guaifenesin, USP 100 mg | Expectorant |
Indications & Usage
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings
Warnings
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis 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.
Dosage & Administration
Directions
- measure only with dosing cup provided
- keep dosing cup with product
- ml = milliliter
- do not take more than 6 doses in any 24-hour period
| age | dose |
|---|---|
| children under 4 years | do not use |
| children 4 to under 6 years | 5 ml every 4 hours |
| children 6 to under 12 years | 10 ml every 4 hours |
| adults and children 12 years and over | 20 ml every 4 hours |
Storage And Handling
Other information
- each 5 ml contains: sodium 3 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose
Otc - Questions
Questions or comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
For most recent product information, visit www.robitussin.com
Principal Display Panel - 118 Ml Bottle Label
Children's
Robitussin®
AGES 4 & OVER
Cough & Chest
Congestion
DM
DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)
Alcohol-Free
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
NEW
Dosing
Information
Children's
Robitussin®
NOW FOR AGES 4 & OVER
Cough & Chest
Congestion
DM
DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)
Relieves:
✓ Chest Congestion/Mucus
✓ Cough
Non-Drowsy
grape
flavor
4 FL OZ
(118 ml)
Principal Display Panel (118 ml Bottle Carton)
* Please review the disclaimer below.
