Other
Drug Facts
Distributed by:
Pfizer, Madison, NJ 07940 USA
For most recent product information, visit www.robitussin.com
Robitussin Mucus Plus Chest Congestion
FDA Label NDC 0031-8724
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Richmond Division Of Wyeth for the product Robitussin Mucus Plus Chest Congestion (NDC 0031-8724). 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, active ingredient (in each 10 ml), purpose, 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)
Guaifenesin, USP 200 mg
Purpose
Expectorant
Use
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- ml=milliliter
- this adult product is not intended for use in children under 12 years of age
| age | dose |
|---|---|
| adults and children 12 years and over | 10-20 ml every 4 hours |
| children under 12 years | do not use |
Other Information
- each 10 ml contains: sodium 4 mg
- store at 20-25°C (68-77°F). Do not refrigerate
- alcohol-free
Inactive Ingredients
anhydrous citric acid, artificial flavor, caramel, FD&C red no. 40, glycerin, high fructose corn syrup, liquid glucose, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate
Questions Or Comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Principal Display Panel - 118 Ml Bottle Label
ADULT
Robitussin®
Mucus + Chest Congestion
GUAIFENESIN (Expectorant)
Alcohol-Free
4 FL OZ (118 ml)
Principal Display Panel (118 mL Bottle Label)
Principal Display Panel - 118 Ml Bottle Carton
ADULT
Robitussin®
Mucus + Chest
Congestion
GUAIFENESIN (Expectorant)
Relieves:
✓ Mucus✓ Chest Congestion
Alcohol-Free
ORIGINAL
For Ages 12 & Over
4 FL OZ
(118 ml)
Principal Display Panel (118 mL Bottle Carton)
* Please review the disclaimer below.
