Label: DEXTROMETHORPHAN HBR 15 MG capsule, liquid filled
- NDC Code(s): 73629-005-10
- Packager: AMZ789 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 May 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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.
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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HBR 15 MG
dextromethorphan hbr 15 mg capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73629-005 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 WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GELATIN (UNII: 2G86QN327L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE (UNII: FZ989GH94E) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (CLEAR) Score score with uneven pieces Shape OVAL (CAPSULE) Size 10mm Flavor Imprint Code PC6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73629-005-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2022 Labeler - AMZ789 LLC (117410213) Establishment Name Address ID/FEI Business Operations Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(73629-005)