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Mucinex DM Maximum Strength by Reckitt Benckiser LLC

Dosage form: tablet, extended release
Ingredients: Guaifenesin 1200mg, Dextromethorphan Hydrobromide 60mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-072

Mucinex®DM

Drug Facts

Active ingredients (in each extended-release bi-layer 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.

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

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Distributed by:
Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 14 Tablet Carton

NDC 63824-072-35

MAXIMUM STRENGTH

Mucinex®DM
1200 mg guaifenesin & 60 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR

Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release

14
EXTENDED-RELEASE
BI-LAYER TABLETS

MUCINEX DM  MAXIMUM STRENGTH
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-072
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 Crosslinked) 
D&C yellow no. 10 
aluminum oxide 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
Product Characteristics
ColorWHITE (yellow and white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-072-071 BLISTER PACK in 1 CARTON
17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63824-072-351 BLISTER PACK in 1 CARTON
214 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:63824-072-362 BLISTER PACK in 1 CARTON
314 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
4NDC:63824-072-463 BLISTER PACK in 1 CARTON
414 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
5NDC:63824-072-484 BLISTER PACK in 1 CARTON
512 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
6NDC:63824-072-182 BLISTER PACK in 1 CARTON
69 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162006/26/2012
Labeler - Reckitt Benckiser LLC (094405024)

 
Reckitt Benckiser LLC

Further information

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

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