FDA Label for Childrens Robitussin Cough Long-acting
View Indications, Usage & Precautions
Childrens Robitussin Cough Long-acting 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.
Active Ingredient (In Each 10 Ml)
Dextromethorphan HBr, USP 15 mg
Purpose
Cough suppressant
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
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.
Otc - Ask Doctor
Ask a doctor before use if you have
1. cough that occurs with too much phlegm (mucus)2. cough that lasts or is chronic such as occurs with smoking, asthma, 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
1. measure only with dosing cup provided2. keep dosing cup with product3. ml = milliliter4. do not take more than 4 doses in any 24-hour period
| age | dose |
|---|---|
children under 4 years | do not use |
children 4 to under 6 years | 5 ml every 6 - 8 hours |
children 6 to | 10 ml |
adults and children | 20 ml |
Other Information
1. each 10 ml contains: sodium 11 mg2. store at 20-25°C (68-77°F)
Inactive Ingredients
anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate
Questions Or Comments?
Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
Distributed by:
Pfizer, Madison, NJ 07940 USA
For most recent product information, visit
www.robitussin.com
Principal Display Panel
NEW
Dosing
Information
Children's
Robitussin®
NOW FOR AGES 4 & OVER
Cough
Long-Acting
DEXTROMETHORPHAN HBr (Cough Suppressant)
Relieves:
✓ Cough Up to 8 Hours
Alcohol-Free
fruit
punch
flavor
4 FL OZ
(118 ml)
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