GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purposes

Cough suppressant
Expectorant

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

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

• store at 20° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

Questions?

call 1-855-274-4122

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO ARHA0825
QUESTIONS? 1-888-423-0139
topcare@topco.com  www.topcarebrand.com

MADE IN INDIA

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-RELEASE

      TABLETS

actual size

 

 

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN HBR 
guaifenesin and dextromethorphan hbr tablet, extended release

Product 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)