MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
American Health Packaging

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Mucinex ® DM
5500411/0122

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)
Dextromethorphan HBr 30 mg
Guaifenesin 600 mg

Purpose

Cough suppressant
Expectorant

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 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other information

  • store at 20-25°C (68-77°F)
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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?

About the product, call RB Health (US) at 1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.

For questions about the packaging and labeling, call American Health Packaging at 1-800 707-4621

The name MUCINEX ® and associated trademarks trademark items are used with permission by RB Health.

The drug product contained in this package is from NDC# 63824-056, RB Health (US).

Distributed by
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

765121
5500411/0122

Package/Label Principal Display Panel – Carton – 600 mg/30 mg

600 mg/30 mg Mucinex DM Extended-Release Tablets Carton

NDC 60687- 651-21

Mucinex ® DM

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

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

Unique Bi-Layer Tablet
Immediate Release Layer
Extended Release Layer

30 Extended-Release Tablets (3 x 10)

Distributed by
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

765121
5500411/0122

Package/Label Display Panel – Blister – 600 mg/30 mg

600 mg/30 mg Mucinex DM Extended-Release Tablet Blister

Mucinex ® DM
EXPECTORANT & COUGH SUPPRESSANT
(guaifenesin/dextromethorphan HBr)
ER Tablet 600 mg/30 mg

MUCINEX DM 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-651(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 HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (white) , yellow (yellow) Scoreno score
ShapeOVALSize16mm
FlavorImprint Code Mucinex;600
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-651-2130 in 1 CARTON07/14/202202/29/2024
1NDC:60687-651-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162007/14/202202/29/2024
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(60687-651)

Revised: 8/2023
Document Id: 025765c9-619a-7e54-e063-6394a90afde3
Set id: c2dfbe0f-238d-4519-b1ed-a11b2137a96e
Version: 2
Effective Time: 20230807
 
American Health Packaging