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Guaifenesin and Dextromethorphan Hydrobromide

Medically reviewed on September 7, 2017

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg, DEXTROMETHORPHAN HYDROBROMIDE 60mg
Labeler: walgreens
NDC Code: 0363-0076

Guaifenesin and Dextromethorphan Hydrobromide

Drug Facts

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

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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack Carton

Well at
Walgreens

NDC 0363-0076-28

MAXIMUM STRENGTH
12 HOUR
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

28
EXTENDED-RELEASE
TABLETS

12
HOUR

Actual Size

Compare to Maximum Strength
Mucinex® DM active ingredients‡‡

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0076
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize16mm
FlavorImprint CodeMucinex;1200
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0076-141 BLISTER PACK in 1 CARTON
114 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:0363-0076-282 BLISTER PACK in 1 CARTON
214 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162009/05/2017
Labeler - walgreens (008965063)
Establishment
NameAddressID/FEIOperations
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD230780363MANUFACTURE(0363-0076), LABEL(0363-0076)

 
walgreens

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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