MUCINEX DM- dextromethorphan hydrobromide and guaifenesin tablet, extended release 
Mechanical Servants LLC

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Mucinex®

DM

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 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.

Dist. by:

R B Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch

Mucinex®DM

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

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR ®

2
extended-release bi-layer tablets

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch


PRINCIPAL DISPLAY PANEL-2 Tablet Pouch 4ct Package

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

4 Extended-Release Bi-layer Tablets

(2 Pouches: 2 tablets each)

Mucinex DM 4ct

MUCINEX  DM
dextromethorphan hydrobromide and guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6647
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (yellow and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6647-11 in 1 BLISTER PACK06/26/2012
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162006/26/2012
MUCINEX  DM
dextromethorphan hydrobromide and guaifenesin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6942
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (yellow and white) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6942-42 in 1 BLISTER PACK07/17/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162007/17/2017
Labeler - Mechanical Servants LLC (005530951)
Establishment
NameAddressID/FEIBusiness Operations
Mechanical Servants LLC005530951repack(29485-6647, 29485-6942) , relabel(29485-6647, 29485-6942)

Revised: 12/2021
Document Id: d208cdfd-3144-c730-e053-2a95a90a8c58
Set id: 0fc54199-9a61-4a63-b5cd-b132e44f23c9
Version: 6
Effective Time: 20211215
 
Mechanical Servants LLC