Label: DEXTROMETHORPHAN HBR 15 MG- dextromethorphan hbr capsule, liquid filled
- NDC Code(s): 53345-028-01
- Packager: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
- 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.
Updated November 8, 2019
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- 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 the user has
- 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.
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - Shipping Label
Dextromethorphan HBr Capsules, 15 mg
Quantity : 12000 Capsules
NDC No. : 53345-028-01
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HBR 15 MG
dextromethorphan hbr capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-028 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (CLEAR) Score no score Shape CAPSULE (OVAL) Size 10mm Flavor Imprint Code 661 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-028-01 1 in 1 BOX 12/10/2014 1 12000 in 1 BAG; 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 12/10/2014 Labeler - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. 421293287 MANUFACTURE(53345-028) , ANALYSIS(53345-028)