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Drug Facts
Distributed by: Pfizer, Madison, NJ 07940 USA
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief Tablet, Extended Release
FDA Label NDC 0031-8765
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 Maximum Strength 12 Hour Cough And Mucus Relief (NDC 0031-8765). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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 extended-release tablet) | Purposes |
|---|---|
| Dextromethorphan HBr 60 mg | Cough suppressant |
| Guaifenesin 1200 mg | Expectorant |
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Warnings
Do Not Use
- for children under 12 years of age
- 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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 (1-800-222-1222).
Dosage & Administration
Directions
- do not crush, chew, or break tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
- children under 12 years of age: do not use
Storage And Handling
Other information
- each tablet contains: magnesium 25 mg
- store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide
Otc - Questions
Questions?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Principal Display Panel - 1200 Mg/60 Mg Tablet Blister Pack
PUSH TABLET THROUGH FOIL
Robitussin® Maximum Strength
12 Hour Cough & Mucus Relief
Extended-Release Tablet
Guaifenesin 1200 mg
Dextromethorphan HBr 60 mg
Extended-Release Tablet
Dist. by: Pfizer, Madison, NJ 07940 USA
©2019 Pfizer Inc.
LOT
EXP
Principal Display Panel - 8 Tablet Blister Pack Carton
NEW!
Robitussin®
MAXIMUM STRENGTH
12 Hour
Cough & Mucus Relief
EXTENDED-RELEASE TABLETS
GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE
1200 mg/60 mg EXTENDED-RELEASE TABLETS
Expectorant & Cough Suppressant
Actual Size
✓Controls Cough
✓Thins & Loosens Mucus
8
EXTENDED-RELEASE TABLETS
* Please review the disclaimer below.
