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: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
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Updated January 6, 2022
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- Active ingredients (in each liquid-filled capsule)
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if 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.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin capsule, liquid filled
Product 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 FINAL part341 05/23/2013 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)