Mucinex DM

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

• 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63824-056-32 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-32) 2 63824-056-34 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-34) 3 63824-056-58 1 BOTTLE In 1 CARTON contains a BOTTLE 3 58 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-056-58) 4 63824-056-72 25 POUCH In 1 CARTON contains a POUCH 4 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-72) 5 63824-056-76 3 POUCH In 1 CARTON contains a POUCH 5 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-76)

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: 12/2009Reckitt Benckiser, Inc.

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