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Mucinex DM

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

Medically reviewed by Drugs.com. Last updated on Apr 1, 2021.

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purposes
Dextromethorphan HBr 30 mg Cough suppressant
Guaifenesin 600 mg 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 tablets every 12 hours; not more than 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other information

  • 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

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 - 20 Tablet Blister Pack Carton

NDC 63824-056-32

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
Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS

Mucinex DM
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (Guaifenesin) Guaifenesin 600 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg
Inactive Ingredients
Ingredient Name Strength
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)
D&C yellow no. 10
aluminum oxide
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE (yellow and white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code Mucinex;600
Contains
Packaging
# Item Code Package Description
1 NDC:63824-056-89 4 BLISTER PACK in 1 CARTON
1 17 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
2 NDC:63824-056-36 1 BLISTER PACK in 1 CARTON
2 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
3 NDC:63824-056-32 1 BLISTER PACK in 1 CARTON
3 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
4 NDC:63824-056-34 2 BLISTER PACK in 1 CARTON
4 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
5 NDC:63824-056-69 3 BLISTER PACK in 1 CARTON
5 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
6 NDC:63824-056-74 24 POUCH in 1 CARTON
6 NDC:63824-056-73 2 TABLET, EXTENDED RELEASE in 1 POUCH
7 NDC:63824-056-72 2 TABLET, EXTENDED RELEASE in 1 POUCH
8 NDC:63824-056-11 2 BLISTER PACK in 1 CARTON
8 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
9 NDC:63824-056-01 5 BLISTER PACK in 1 CARTON
9 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
10 NDC:63824-056-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021620 06/26/2012
Labeler - RB Health (US) LLC (081049410)
RB Health (US) LLC

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