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Childrens Robitussin Cough and Cold CF

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, GUAIFENESIN 50mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8716

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.

CHILDREN'S ROBITUSSIN® COUGH & COLD CF

Drug Facts

Active ingredients
(in each 5 mL tsp)
Purposes
Dextromethorphan HBr, USP 5 mgCough suppressant
Guaifenesin, USP 50 mgExpectorant
Phenylephrine HCl, USP 2.5 mgNasal decongestant

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves these symptoms occurring with a cold:
    • nasal congestion
    • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • 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
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • 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
  • do not take more than 6 doses in any 24-hour period
agedose
children under 6 yearsdo not use
children 6 to under 12 years2 teaspoons every 4 hours
adults and children
12 years and over
4 teaspoons every 4 hours

Other information
  • each teaspoon contains: sodium 3 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.
  • dosage cup provided

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 - 118 mL Bottle Carton

Children's
Robitussin
®
Cough & Cold

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

CF

NON-DROWSY

RELIEVES:

Cough
Chest Congestion/Mucus
Stuffy Nose

See NEW Dosing
Information

GRAPE Flavor

For Children Ages 6 & Over

4 FL OZ (118 ml)

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN50 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL, (R)- 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorRED (clear red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8716-121 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/01/2009
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245ANALYSIS(0031-8716), LABEL(0031-8716), MANUFACTURE(0031-8716), PACK(0031-8716), RELABEL(0031-8716), REPACK(0031-8716)

Revised: 09/2012
 
Richmond Division of Wyeth

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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