CHILDRENS ROBITUSSIN COUGH LONG-ACTING- dextromethorphan hydrobromide liquid

SPL UNCLASSIFIED SECTION

Drug Facts
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
Warnings
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, or emphysema
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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 ml every 6 - 8 hours
children 6 to under 12 years	10 ml every 6 to 8 hours
adults and children 12 years and older	20 ml every 6 to 8 hours

Other information
- each 10 ml contains: sodium 11 mg
- 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 - 118 ml Bottle Label

Children's
Robitussin®
AGES 4 & OVER

Cough

Long-Acting

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves Cough up to 8 Hours

Alcohol-Free
4 FL OZ (118 ml)
PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

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)

INGREDIENTS AND APPEARANCE

CHILDRENS ROBITUSSIN COUGH LONG-ACTING
dextromethorphan hydrobromide liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0031-8694-12	1 in 1 CARTON	07/01/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	01/01/2004

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Childrens Robitussin Cough Long-Acting by