FDA Label for Childrens Robitussin Honey 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
Childrens Robitussin Honey Cough And Chest Congestion Dm Product Label
The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) 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 10 ml) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 10 mg | Cough suppressant |
| Guaifenesin, USP 100 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
| age | dose |
|---|---|
| children under 4 years | do not use |
| children 4 to under 6 years | 5 ml every 4 hours |
| children 6 to under 12 years | 10 ml every 4 hours |
| adults and children 12 years and over | 20 ml every 4 hours |
Storage And Handling
Other information
- each 10 ml contains: sodium 11 mg
- store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, 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
Children's
Robitussin®
Honey
For Ages 4+
Cough & Chest
Congestion
DM
DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)
NON-DROWSY
4 FL OZ (118 ml)
Principal Display Panel - 118 Ml Bottle Carton
Children's
NEW!
Robitussin®
Honey
For Ages 4+
Cough & Chest
Congestion
DM
DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)
NON-DROWSY
Relieves:
✓ Chest congestion
✓ Mucus
✓ Cough
Taste the
Real Honey
TRUE
SOURCE
CERTIFIED
HONEY✓
4 FL OZ (118 ml)
* Please review the disclaimer below.