CHILDRENS ROBITUSSIN COUGH AND COLD CF- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 10 ml)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

1.
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
2.
temporarily relieves these symptoms occurring with a cold:
1.
nasal congestion
2.
cough due to minor throat and bronchial irritation

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

1.
heart disease
2.
high blood pressure
3.
thyroid disease
4.
diabetes
5.
trouble urinating due to an enlarged prostate gland
6.
cough that occurs with too much phlegm (mucus)
7.
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

Stop use and ask a doctor if

1.
you get nervous, dizzy, or sleepless
2.
symptoms do not get better within 7 days or are accompanied by fever
3.
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

1.
measure only with dosing cup provided
2.
keep dosing cup with product
3.
ml = milliliter
4.
do not take more than 6 doses in any 24-hour period
agedose

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

Other information

1.
each 10 ml contains: sodium 7 mg
2.
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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 & Cold

CF

DEXTROMETHORPHAN HBr
(Cough Suppressant)
GUAIFENESIN (Expectorant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Chest Congestion/Mucus
Stuffy Nose

Non-Drowsy

grape
flavor

4 FL OZ
(118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
CHILDRENS ROBITUSSIN COUGH AND COLD CF 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8716
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorRED (clear red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8716-121 in 1 CARTON09/01/2009
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 finalpart34109/01/2009
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 10/2020
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC