FDA Label for Robitussin Maximum Strength Cough Plus Chest Congestion Dm
View Indications, Usage & Precautions
Robitussin Maximum Strength Cough Plus Chest Congestion Dm Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: Pfizer, Madison, NJ 07940 USA
Otc - Purpose
| Active ingredients (in each liquid-filled capsule) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 10 mg | Cough suppressant |
| Guaifenesin, USP 200 mg | Expectorant |
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
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.
Directions
- do not take more than 12 capsules in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
| age | dose |
|---|---|
| adults and children 12 years and over | 2 capsules every 4 hours |
| children under 12 years | do not use |
Other Information
- store at 20-25°C (68-77°F).
- avoid excessive heat above 40°C (104°F).
Inactive Ingredients
FD&C Red No. 40, gelatin, glycerin, light mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Made in Canada
For most recent product information, visit www.robitussin.com
Principal Display Panel - 20 Capsule Blister Pack Carton
ADULT
Robitussin®
MAXIMUM
STRENGTH
Cough+Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
DM
MAX
Relieves:
✓ Cough✓ Mucus
Non-Drowsy
For Ages 12 & Over
20
LIQUID-FILLED
CAPSULES
* Please review the disclaimer below.