NDC | 67091-314-20 |
Set ID | e7e16bab-a7aa-4911-9a29-0c986b26da67 |
Category | Human OTC Drug Label |
Packager | Winco Foods, LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA206941 |
- Active Ingredients
- Purpose
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- temporarily relieves:
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
-
Warnings
Do not use
- for children under 12 years of age
- 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
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose Tablets
Winco®
FOODS
Compare to the active ingredients
in Mucinex® DM
NDC 67091-314-20
Mucus Relief DM
EXPECTORANT &
COUGH SUPPRESSANT
Guaifenesin and
DEXTROMETHORPHAN HBr30 mg/
COUGH SUPPRESSANT
GUAIFENESIN 600 mg / EXPECTORANT
Controls Cough for 12 Hours
Thins and Loosens Mucus
20 Tablets
Extended-release Tablets
for 12-Hour Relief
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM EXPECTORANT AND COUGH SUPPRESSANT
guaifenesin and dextromethorphan hbr tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-314 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K90 (UNII: RDH86HJV5Z) POVIDONE K25 (UNII: K0KQV10C35) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 16mm Flavor Imprint Code X;62 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-314-20 2 in 1 CARTON 03/17/2017 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206941 03/17/2017 Labeler - Winco Foods, LLC. (056098817) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(67091-314) , MANUFACTURE(67091-314)