MEMBERS MARK MUCUS RELIEF DM- guaifenesin and dextromethorphan hbr tablet, extended release 
SAM'S WEST INC

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Drug Facts

Active ingredients

(in each extended-release tablet)

Guaifenesin USP, 1200 mg

Dextromethorphan Hydrobromide USP, 60 mg

Purposes

Expectorant

Cough suppressant

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 type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions

call 1-888-375-3784 Weekdays (8am - 8pm EST)

You may also report side effects to this phone number.

Distributed by:

SAM'S WEST, INC.

BENTONVILLE, AR 72716

Made in India

Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets

Carton:

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MEMBERS MARK MUCUS RELIEF DM 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-999(NDC:43598-115)
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
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)  
HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorWHITE (white to off white) , GREEN (light green to green) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-999-564 in 1 CARTON05/30/2024
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21734008/15/2023
Labeler - SAM'S WEST INC (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited- FTO3918608162manufacture(68196-999) , analysis(68196-999)

Revised: 3/2024
Document Id: 2e54a2dd-fe77-5d11-a11c-735a631c7b71
Set id: 2b59f90b-b8fc-03c0-3527-a8efa97fbfe3
Version: 1
Effective Time: 20240313
 
SAM'S WEST INC