Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release
- NDC Code(s): 76162-032-56
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 23, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
-
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
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg/1200 mg Blister Carton 56 (8 x 7) Unit-Dose Tablets
TopCare®
health
NDC 76162-032-56
COMPARE TO THE ACTIVE
INGREDIENTS OF MAXIMUM
STRENGTH MUCINEX® DM*
MAXIMUM STRENGTH
Mucus DM
DEXTROMETHORPHAN HBr and GUAIFENESIN
EXTENDED-RELEASE TABLETS
60 mg/1200 mg
DEXTROMRTHORPHAN HBr 60 mg - COUGH SUPPRESSANT
GUAIFENESIN 1200 mg - EXPECTORANT
RELIEVES COUGH & CHEST CONGESTION
12
HOUR
• Controls Cough
• Thins & Loosens Mucus
FOR DAY
OR NIGHT
56 EXTENDED-RELEASETABLETS
actual size
-
INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hbr tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-032 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:76162-032-56 8 in 1 CARTON 04/23/2026 1 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 04/23/2026 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(76162-032) , MANUFACTURE(76162-032)