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Mucinex DM by Reckitt Benckiser LLC

Dosage form: tablet, extended release
Ingredients: Guaifenesin 600mg, Dextromethorphan Hydrobromide 30mg
Labeler: Reckitt Benckiser LLC
NDC Code: 63824-056

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 mgCough suppressant
Guaifenesin 600 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 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 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
©2012 RB

Made in England

PRINCIPAL DISPLAY PANEL - 20 Tablet Carton

NDC 63824-056-32

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

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR

Controls Cough
Thins And Loosens Mucus

20 extended-release bi-layer tablets

MUCINEX DM 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-056
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin600 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 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
ShapeOVALSize16mm
FlavorImprint CodeMucinex;600
Contains    
Packaging
#Item CodePackage Description
1NDC:63824-056-321 BLISTER PACK in 1 CARTON
120 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:63824-056-344 BLISTER PACK in 1 CARTON
210 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:63824-056-361 BLISTER PACK in 1 CARTON
36 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
4NDC:63824-056-581 BOTTLE in 1 CARTON
458 TABLET, EXTENDED RELEASE in 1 BOTTLE
5NDC:63824-056-7225 POUCH in 1 CARTON
52 TABLET, EXTENDED RELEASE in 1 POUCH
6NDC:63824-056-763 POUCH in 1 CARTON
62 TABLET, EXTENDED RELEASE in 1 POUCH
7NDC:63824-056-542 POUCH in 1 CARTON
72 TABLET, EXTENDED RELEASE in 1 POUCH
8NDC:63824-056-696 BLISTER PACK in 1 CARTON
810 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)

Revised: 09/2012
 
Reckitt Benckiser LLC

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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