Label: ROBITUSSIN CF- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
- NDC Code(s): 0031-8678-82
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 17, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ROBITUSSIN CF
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquidProduct 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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)