GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
SAM'S WEST INC

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Guaifenesin and Dextromethorphan HBr

Drug Facts

Active ingredients (in each extended-release tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

Uses

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

Other information

Inactive ingredients

carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Questions?

(1-800-406-7984)

You may also report side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 56 Extended-Release Tablet Blister Pack Carton

Compare to Maximum Strength Mucinex® DM
active ingredients*

NDC 68196-997-56

Member's Mark

Maximum Strength
Mucus Relief DM

Guaifenesin 1200 mg &
Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant & Cough Suppressant

12
HOUR

56
Extended-
Release
Tablets

PRINCIPAL DISPLAY PANEL - 56 Extended-Release Tablet Blister Pack Carton
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-997
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin1200 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide60 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE K30 (UNII: U725QWY32X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code 053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-997-561 in 1 CARTON02/16/2022
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21478102/16/2022
Labeler - SAM'S WEST INC (051957769)
Registrant - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002MANUFACTURE(68196-997)

Revised: 2/2022
Document Id: 298f18eb-cec6-44f9-8e92-a393c5975a65
Set id: a9d9d90c-5e9a-4ca6-a667-f04cb1d64c7f
Version: 2
Effective Time: 20220223
 
SAM'S WEST INC