MUCINEX DM - guaifenesin and dextromethorphan hydrobromide tablet, extended release 
Physicians Total Care, Inc.

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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

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

Other information

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



Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 54868-5853-0

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

Principal Display Panel

MUCINEX DM 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5853(NDC:63824-056)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (yellow and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5853-02 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162001/23/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 12/2009
Document Id: 558086c7-d31d-4e1d-b40c-83bec73cd5f4
Set id: 25936338-9474-4b53-bd74-ff8c92d151b5
Version: 1
Effective Time: 20091223
 
Physicians Total Care, Inc.