NDC | 62732-9009-1, 62732-9009-2 |
Set ID | 3d233b7c-1f46-5fd7-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Yichang Humanwell Pharmaceutical Co. Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- Uses
-
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 a MAOI, ask a doctor or pharmacist before using this product.
Ask a doctor before use if you have
■ persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough that is accompanied by excessive phlegm (mucus)
- Directions
- Other information
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62732-9009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K29/32 (UNII: 390RMW2PEQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (White to off white) Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code L3Z9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62732-9009-1 200 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2017 2 NDC:62732-9009-2 17000 in 1 BAG; Type 0: Not a Combination Product 04/21/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/03/2017 Labeler - Yichang Humanwell Pharmaceutical Co. Ltd. (527225336)