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Mucinex DM Prescribing Information

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

Medically reviewed by Last updated on Aug 24, 2023.

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purposes
Dextromethorphan HBr 30 mgCough suppressant
Guaifenesin 600 mgExpectorant

Indications and Usage for Mucinex DM

  • 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


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 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 or 2 tablets every 12 hours; not more than 4 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 #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF


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 - 20 Tablet Blister Pack Carton

NDC 63824-056-32


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



Controls Cough
Thins and Loosens Mucus
Immediate and Extended Release


PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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)
magnesium stearate (UNII: 70097M6I30)
Product Characteristics
ColorWHITE (yellow and white) Scoreno score
FlavorImprint CodeMucinex;600
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63824-056-894 in 1 CARTON03/30/2018
117 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63824-056-361 in 1 CARTON06/26/2012
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:63824-056-321 in 1 CARTON06/26/2012
320 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:63824-056-342 in 1 CARTON06/26/2012
420 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:63824-056-693 in 1 CARTON06/26/2012
520 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:63824-056-7424 in 1 CARTON06/26/2012
6NDC:63824-056-732 in 1 POUCH; Type 0: Not a Combination Product
7NDC:63824-056-722 in 1 POUCH; Type 0: Not a Combination Product06/26/2012
8NDC:63824-056-112 in 1 CARTON06/26/201206/15/2022
812 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:63824-056-015 in 1 CARTON06/26/2012
920 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:63824-056-50500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - RB Health (US) LLC (081049410)

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