FDA Label for Childrens Robitussin 12 Hour Cough Relief
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTHER
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENTS (GRAPE FLAVOR)
- INACTIVE INGREDIENTS (ORANGE FLAVOR)
- OTC - QUESTIONS
- PRINCIPAL DISPLAY PANEL - 89 ML BOTTLE CARTON - ORANGE
- PRINCIPAL DISPLAY PANEL - 89 ML BOTTLE CARTON - GRAPE
Childrens Robitussin 12 Hour Cough Relief 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.
Otc - Active Ingredient
Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP
Otc - Purpose
Purpose
Cough suppressant
Indications & Usage
Uses
temporarily relieves
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants• the impulse to cough to help you get to sleep
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.
Other
Allergy Alert
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Distributed by: Pfizer, Madison, NJ 07940 USA © 2016 Pfizer Inc.
Otc - Ask Doctor
Ask a doctor before use if you have
• chronic cough that lasts as occurs with smoking, asthma, or emphysema• cough that occurs with too much phlegm (mucus)
Otc - Stop Use
Stop use and ask a doctor if
• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.• cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 1-800-222-1222.
Dosage & Administration
Directions
• shake bottle well before use• measure only with dosing cup provided. Do not use dosing cup with other products• dose as follows or as directed by doctor• mL = milliliter
adults and children 12 years of age and over | 10 mL every 12 hours, not to exceed 20 mL in 24 hours |
children 6 to under 12 years of age | 5 mL every 12 hours, not to exceed 10 mL in 24 hours |
children 4 to under 6 years of age | 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
children under 4 years of age | do not use |
Storage And Handling
Other information
• each 5 mL contains: sodium 5 mg• store at 20–25°C (68–77°F)• dosing cup provided
Inactive Ingredients (Grape Flavor)
D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Inactive Ingredients (Orange Flavor)
D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Otc - Questions
Questions?
call weekdays from 9 AM to 5 PM EST at 1-800-762-4675.
You may also report side effects to this number.
For most recent product information, visit www.robitussin.com
Principal Display Panel - 89 Ml Bottle Carton - Orange
NEW!
Children's
Robitussin®
For adults & children
AGES 4 & OVER
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Orange Flavored Liquid
Alcohol-Free
3 FL OZ (89 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
Principal Display Panel - 89 Ml Bottle Carton - Grape
NEW!
Children's
Robitussin®
For adults & children
AGES 4 & OVER
EXTENDED-RELEASE
12 Hour
Cough Relief
DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)
12 Hour
Cough Relief
DAY or NIGHT
Grape Flavored Liquid
Alcohol-Free
3 FL OZ (89 mL)
Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions
* Please review the disclaimer below.