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Distributed by:
Pfizer, Madison, NJ 07940 USA
Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm Solution
FDA Label NDC 0031-8759
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 Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm (NDC 0031-8759). 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, ask a doctor before use if you have, 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 20 ml) | Purposes |
|---|---|
Dextromethorphan HBr, USP 20 mg | Cough suppressant |
Guaifenesin, USP 200 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.
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
- 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 | 20 ml every 4 hours |
children under 12 years | do not use |
Storage And Handling
Other information
- each 20 ml contains: sodium 20 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, xanthan gum
Otc - Questions
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®
SUGAR-FREE
DYE-FREE
Cough+Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
Non-Drowsy
4 FL OZ (118 ml)
Principal Display Panel (118 ml Bottle Label)
Principal Display Panel - 118 Ml Bottle Carton
ADULT
See
New
Dosing
Robitussin®
SUGAR-FREE
DYE-FREE
Cough+Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
1. Controls Cough2. Relieves Chest Congestion3. Thins & Loosens Mucus
Specially Formulated
for DIABETICS
Non-Drowsy
DM
SUGAR-FREE
DYE-FREE
BETTER
TASTING!
Same Effective
Cough Relief*
For Ages 12 & Over
4 FL OZ
(118 ml)
Principal Display Panel (118 ml Bottle Carton)
* Please review the disclaimer below.
