NDC | 68016-315-14, 68016-315-28 |
Set ID | 65083cb7-e30c-43d4-99e5-fc86debd1a98 |
Category | Human OTC Drug Label |
Packager | Chain Drug Consortium, 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
-
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?
call 1-855-274-4122 You may also report side effects to this phone number.
Distributed By:
Pharmacy Value Alliance LLC,
407 East Lancaster Avenue, Wayne,
PA 19087.
MADE IN INDIA
Code: TS/DRUGS/22/2009
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® DM.
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)
Premier Value®
Compare to the active ingredients of
Maximum Strength Mucinex® DM*
MAXIMUM STRENGTH
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets
1200 mg/60 mg
EXPECTORANT AND COUGH SUPPRESSANT
12 HR- Controls Cough
- Thins and Loosens Mucus
14 (2X7)
Extended-release Tablets
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM
guaifenesin and dextromethorphan hbr tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-315 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 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 22mm Flavor Imprint Code X;63 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-315-14 2 in 1 CARTON 03/17/2017 1 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:68016-315-28 4 in 1 CARTON 03/17/2017 2 7 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 - Chain Drug Consortium, LLC (101668460) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(68016-315) , MANUFACTURE(68016-315)