Your browser does not support JavaScript! MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

MUCINEX DM (guaifenesin and dextromethorphan hydrobromide) tablet
[Lil' Drug Store Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 pouch is broken or torn
  • 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.

Product manufactured by:
Reckitt Benckiser, Parsippany, NJ 07054-0224

Repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

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

2 TABLETS
extended-release bi-layer tablets

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton
MUCINEX DM 
guaifenesin and dextromethorphan hydrobromide tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66715-9724(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 Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9724-11 in 1 CARTON
12 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162005/10/2010
Labeler - Lil' Drug Store Products, Inc. (093103646)
Establishment
NameAddressID/FEIBusiness Operations
CCB Packaging Inc.362374464REPACK(66715-9724), RELABEL(66715-9724)
Establishment
NameAddressID/FEIBusiness Operations
Reckitt Benckiser Pharmaceuticals, Inc.832277599MANUFACTURE(66715-9724)

Revised: 12/2012
 
Lil' Drug Store Products, Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services