Label: ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, liquid filled
- NDC Code(s): 0031-8719-10, 0031-8719-20, 0031-8719-31, 0031-8719-70
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 15, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each liquid-filled capsule)
- Uses
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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
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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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8719 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color RED (clear red) Score no score Shape OVAL (oblong) Size 16mm Flavor Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8719-10 5 in 1 CARTON 05/02/2016 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0031-8719-20 10 in 1 CARTON 05/23/2013 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:0031-8719-31 15 in 1 CARTON 05/23/2013 12/31/2018 3 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:0031-8719-70 500 in 1 BOX 05/23/2013 12/31/2018 4 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/23/2013 Labeler - Haleon US Holdings LLC (079944263)