Guaifenesin and Dextromethorphan HBr by Sam's West Inc / Aurohealth LLC / Aurobindo Pharma Limited Drug Facts

Guaifenesin and Dextromethorphan HBr by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan HBr by is a Otc medication manufactured, distributed, or labeled by Sam's West Inc, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN AND DEXTROMETHORPHAN HBR - guaifenesin and dextromethorphan hbr tablet, extended release 
Sam's West Inc

----------

Drug Facts

Active ingredients

(in each extended-release tablet)

Dextromethorphan HBr 60 mg
Guaifenesin 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 right away (1-800-222-1222).

Directions

• do not crush, chew, or break 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 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• Store between 20-25°C (68-77°F)

Inactive ingredients

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

Questions?

call 1-800-406-7984
You may also report side effects to this phone number.

DISTRIBUTED BY:
SAM’S WEST, INC.
BENTONVILLE, AR 72716

PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (56 Extended-Release Tablets Blister Carton Label)

Compare to Maximum Strength Mucinex® DM
active ingredients*

NDC: 68196-942-56

Member's Mark™

Maximum Strength
Mucus Relief DM
Guaifenesin 1200 mg &
Dextromethorphan HBr 60 mg
Extended-Release Tablets Expectorant & Cough Suppressant

    Controls cough
    Thins and loosens mucus

12
HOUR

63
actual size

56
Extended-
Release
Tablets

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-942
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: 68196-942-56	8 in 1 CARTON	07/28/2023	09/08/2023
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	07/28/2023	09/08/2023

Labeler - Sam's West Inc (051957769)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(68196-942) , MANUFACTURE(68196-942)

Revised: 9/2023

Document Id: c276cd36-3378-43bd-b409-1d2ddbd4be48

34390-5

Set id: fd989792-27d7-8c0d-e053-6294a90a85be

Version: 3

Effective Time: 20230908