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Mucinex DM Maximum Strength: Package Insert / Prescribing Info

Package insert / product label
Generic name: guaifenesin and dextromethorphan hydrobromide
Dosage form: tablet, extended release
Drug class: Upper respiratory combinations

Medically reviewed by Drugs.com. Last updated on Aug 27, 2023.

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purposes
Dextromethorphan HBr 60 mgCough suppressant
Guaifenesin 1200 mgExpectorant

Indications and Usage for Mucinex DM Maximum Strength

  • 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.

Mucinex DM Maximum Strength Dosage and Administration

  • 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 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years of age: do not use

Storage and Handling

  • store at 20-25°C (68-77°F)

Inactive ingredients

carbomer homopolymer type B; D&C yellow no. 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: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 14 Tablet Blister Pack Carton

NDC 63824-072-35
MAXIMUM STRENGTH

Mucinex®DM
1200 mg guaifenesin & 60 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR ®

  • Controls Cough
  • Thins and Loosens Mucus
  • Immediate and Extended Release

14
EXTENDED-RELEASE
BI-LAYER TABLETS

Principal Display Panel - 14 Tablet Blister Pack Carton
MUCINEX DM MAXIMUM STRENGTH
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 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)
Product Characteristics
Colorwhite (yellow and white) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-072-071 in 1 CARTON06/26/2012
17 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-072-351 in 1 CARTON06/26/2012
214 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-072-362 in 1 CARTON06/26/2012
314 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-072-463 in 1 CARTON06/26/2012
414 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:63824-072-484 in 1 CARTON06/26/201209/01/2025
512 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:63824-072-182 in 1 CARTON06/26/201206/15/2022
69 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:63824-072-564 in 1 CARTON07/01/2021
714 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:63824-072-021 in 1 CARTON08/01/2021
81 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162006/26/2012
Labeler - RB Health (US) LLC (081049410)

Medical Disclaimer