Medication Guide App

Mucinex DM

Pronunciation

Generic Name: guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet, extended release

Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 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

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  • 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.

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 or 2 tablets every 12 hours; not more than 4 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 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 63824-056-32

Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

20 EXTENDED-RELEASE BI-LAYER TABLETS

Mucinex DM 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-056
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg
Product Characteristics
Color WHITE (yellow and white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains         
Packaging
# Item Code Package Description
1 NDC:63824-056-32 2 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2 NDC:63824-056-34 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
2 10 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
3 NDC:63824-056-58 1 BOTTLE (BOTTLE) in 1 CARTON
3 58 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE
4 NDC:63824-056-72 25 POUCH (POUCH) in 1 CARTON
4 2 TABLET, EXTENDED RELEASE (TABLET) in 1 POUCH
5 NDC:63824-056-76 3 POUCH (POUCH) in 1 CARTON
5 2 TABLET, EXTENDED RELEASE (TABLET) in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021620 03/31/2009
Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009
 
Reckitt Benckiser, Inc.



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