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Mucus DM by Amerisource Bergen

Medically reviewed on April 19, 2018

Dosage form: tablet, extended release
Ingredients: GUAIFENESIN 1200mg, DEXTROMETHORPHAN HYDROBROMIDE 60mg
Labeler: Amerisource Bergen
NDC Code: 46122-420

Drug Facts

Active ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg

Purpose

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 (1-800-222-1222) right away.

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 at 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions?

call 1-855-274-4122  You may also report side effects to this phone number.

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® DM.

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087

Questions or Concerns?
www.mygnp.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)

Compare to Maximum
Strength Mucinex® DM
active ingredients*

GOOD
NEIGHBOR
PHARMACY®

NDC 46122-420-74
12 Hour
maximum strength
Mucus . DM
guaifenesin and dextromethorphan HBr
extended-release tablets
1200 mg/60 mg
Expectorant/Cough Suppressant

  • Controls Cough
  • Thins and Loosens Mucus

14 Extended-Release Tablets

MUCUS DM 
guaifenesin and dextromethorphan hbr tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-420
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
SILICON DIOXIDE 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POVIDONE K90 
POVIDONE K25 
STARCH, CORN 
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeX;63
Contains    
Packaging
#Item CodePackage Description
1NDC:46122-420-742 BLISTER PACK in 1 CARTON
17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:46122-420-034 BLISTER PACK in 1 CARTON
27 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20694103/17/2017
Labeler - Amerisource Bergen (007914906)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited650381903ANALYSIS(46122-420), MANUFACTURE(46122-420)
Establishment
NameAddressID/FEIOperations
Aurobindo Pharma Limited918917626API MANUFACTURE(46122-420)

 
Amerisource Bergen

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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