Label: ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS- dextromethorphan hbr capsule, liquid filled
- NDC Code(s): 0031-8741-20
- 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 January 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)
- PURPOSE
- USE
-
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
- •
- a cough that occurs with too much phlegm (mucus)
- •
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
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PRODUCT PACKAGING
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
ADULT
Robitussin LINGERING COLD Long-Acting CoughGels
DEXTROMETHORPHAN HBr (Cough Suppressant)
Relieves: Cough for up to 8 Hours
Non-Narcotic Formula
Non-Drowsy
For Ages 12 & Over
20 LIQUI-GELS*
*Liquid-Filled Capsules
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
Stop use and ask a doctor if cough lasts more than 7 days.
Pfizer, Madison, NJ 07940 USA © 2011 Pfizer Inc.
For most recent product information, visit www.robitussin.com
LIQUI-GELS is a trademark or registered trademark of Catalent Pharma Solutions.
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INGREDIENTS AND APPEARANCE
ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELS
dextromethorphan hbr capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8741 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 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 (clear red) Score no score Shape OVAL (oval softgel) Size 10mm Flavor Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8741-20 1 in 1 BLISTER PACK 06/06/2011 06/01/2022 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 06/06/2011 06/01/2022 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0031-8741) , LABEL(0031-8741) , PACK(0031-8741)