Label: ROBITUSSIN LONG-ACTING COUGHGELS- dextromethorphan hydrobromide capsule, liquid filled
- NDC Code(s): 0031-8743-20
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 2, 2020
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
- a cough that occurs with too much phlegm (mucus)
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ROBITUSSIN LONG-ACTING COUGHGELS
dextromethorphan hydrobromide capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8743 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) COCONUT OIL (UNII: Q9L0O73W7L) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape OVAL Size 10mm Flavor Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8743-20 1 in 1 CARTON 01/04/2019 1 20 in 1 BOTTLE; 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 01/04/2019 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0031-8743) , LABEL(0031-8743) , PACK(0031-8743)