Label: COUGH RELIEF- dextromethorphan hbr capsule, liquid filled
- NDC Code(s): 33992-0666-5
- Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
- 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 October 7, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
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)
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts. These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
COMPARE TO ACTIVE INGREDIENT OF ROBITUSSIN® LONG-ACTING COUGHGELS®*
ADULT LONG LASTING
• Dextromethorphan HBr, 15 mg
Relieves cough for up to 8 hours, Non-Drowsy
This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Robitussin® Long-Acting CoughGels®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
- Package Label
INGREDIENTS AND APPEARANCE
dextromethorphan hbr capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0666 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) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 12mm Flavor Imprint Code 404 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0666-5 1 in 1 BOX 06/30/2017 12/31/2023 1 15 in 1 BOTTLE, PLASTIC; 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 06/30/2017 12/31/2023 Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)