ROBITUSSIN CF- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid

Robitussin CF by

Drug Labeling and Warnings

Robitussin CF by is a Otc medication manufactured, distributed, or labeled by Richmond Division of Wyeth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5 mL tsp)	Purpose
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Guaifenesin, USP 100 mg	Expectorant
Pseudoephedrine HCl, USP 30 mg	Nasal decongestant

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves these symptoms occurring with a cold:
  • nasal congestion
  • cough due to minor throat and bronchial irritation

WARNINGS

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOl) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOl, 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

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.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 4 doses in any 24-hour period

age	dose
adults and children 12 years and over	2 teaspoonfuls every 4 hours
children 6 years to under 12 years	1 teaspoonful every 4 hours
under 6 years	Do not use

INACTIVE INGREDIENT

Inactive ingredients

citric acid, FD&C red no. 40, flavors, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help right away.

STORAGE AND HANDLING

Other information

• store at 20-25°C (68-77°F)
• dosage cup provided

QUESTIONS

MADE IN U.S.A.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Wyeth®

Robitussin®

CF

NASAL DECONGESTANT
COUGH SUPPRESSANT
EXPECTORANT

• CLEARS
  NASAL STUFFINESS
• CONTROLS COUGHS
• LOOSENS and RELIEVES
  CHEST CONGESTION

COUGH FORMULA
For Children and Adults

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBITUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8678
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8678-82	1 in 1 CARTON	07/01/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		07/01/2015

Labeler - Wyeth Consumer Healthcare LLC (828831730)