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

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Guaifenesin 1200 mg & Dextromethorphan HBr 60 mg Extended-Release Tablets

Drug Facts

Active ingredients (in each extended-release tablet)Purposes

Dextromethorphan HBr 60 mg

Cough suppressant

Guaifenesin 1200 mg

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

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
store between 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

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 - 1200 mg/60 mg Tablet Blister Pack Carton

Compare to Maximum Strength Mucinex® DM
active ingredients*

NDC 68196-073-56

Member's Mark

12
HOUR

Maximum Strength

Mucus Relief DM

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

Controls cough
Thins and loosens mucus
Immediate and Extended Release

actual size

56
Extended-
Release
Tablets

PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack Carton
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-073
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)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize22mm
FlavorImprint Code xeunciM;1200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-073-564 in 1 CARTON10/31/2017
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162010/31/2017
Labeler - SAM'S WEST INC (051957769)
Establishment
NameAddressID/FEIBusiness Operations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(68196-073) , LABEL(68196-073)

Revised: 11/2018
Document Id: 3cb3ab6b-b6b9-4dbf-a21f-7d5423cc510e
Set id: d5e2b1f7-d610-4600-9479-d2f14bcbc92e
Version: 6
Effective Time: 20181105
 
SAM'S WEST INC