Label: ROBITUSSIN DIRECT COUGH- dextromethorphan hydrobromide capsule, liquid filled
- NDC Code(s): 0031-9302-01
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 18, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not useif 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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
-
Additional Information
Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.
Should be 18 or older to purchase
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Lift Here for More Drug Facts
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
visit www.robitussin.com
Trademarks owned or licensed by GSK.
©2022 GSK or licensor.
Made in India
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ROBITUSSIN DIRECT COUGH
dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-9302 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:0031-9302-01 18 in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/15/2022 Labeler - Haleon US Holdings LLC (079944263)