FDA Label for Robitussin Honey Maximum Strength Cough And Chest Congestion Dm
View Indications, Usage & Precautions
- 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
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Robitussin Honey Maximum Strength Cough And 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 20 ml) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 20 mg | Cough suppressant |
| Guaifenesin, USP 400 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 21 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
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®
Honey
MAXIMUM STRENGTH
Cough+Chest
Congestion DM
DM
MAX
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
NON-DROWSY
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
ADULT
NEW!
Robitussin®
Honey
Cough+Chest
Congestion DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
NON-DROWSY
MAXIMUM STRENGTH
✓ Controls Cough✓ Relieves Chest Congestion✓ Thins & Loosens Mucus
Taste the
Real Honey
DM
MAX
For Ages 12+
4 FL OZ (118 ml)
* Please review the disclaimer below.