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Drug Facts
Distributed by:
Pfizer, Madison, NJ 07940 USA
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Maximum Strength Nighttime Cough Dm (NDC 0031-8718). 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, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Distributed by:
Pfizer, Madison, NJ 07940 USA
| Active ingredients (in each 20 ml) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 30 mg | Cough suppressant |
| Doxylamine Succinate, USP 12.5 mg | Antihistamine |
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
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.
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.
| age | dose |
|---|---|
| adults and children 12 years and over | 20 ml every 6 hours |
| children under 12 years | do not use |
anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum
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Made in Canada
For most recent product information, visit www.robitussin.com
ADULT
Robitussin®
MAXIMUM STRENGTH
Nighttime
Cough DM
DM
NIGHTTIME
MAX
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)
4 FL OZ (118 ml)
See
New
Dosing
ADULT
Robitussin®
MAXIMUM STRENGTH
Nighttime
Cough DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)
DM
NIGHTTIME
MAX
BETTER
TASTING!
Same Effective
Nighttime Relief*
For Ages 12 & Over
4 FL OZ (118 ml)
* Please review the disclaimer below.