CHILDRENS ROBITUSSIN COUGH LONG-ACTING- dextromethorphan hydrobromide liquid 
Haleon US Holdings LLC

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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 useif 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

  1. cough that occurs with too much phlegm (mucus)
  2. cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Stop use and ask a doctor ifcough 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

  1. measure only with dosing cup provided
  2. keep dosing cup with product
  3. ml = milliliter
  4. do not take more than 4 doses in any 24-hour period
agedose

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

  1. each 10 ml contains:sodium 11 mg
  2. 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)

Principal Display Panel  - 118 ml Bottle Carton
CHILDRENS ROBITUSSIN COUGH LONG-ACTING 
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8694
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Colorred (bright red) Score    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8694-121 in 1 CARTON07/01/2015
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/01/2004
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 13de389a-3701-8e4c-e063-6294a90a2587
Set id: 75bc7827-4439-e6a8-a65c-7154d5592e58
Version: 10
Effective Time: 20240317
 
Haleon US Holdings LLC