MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
RB Health (US) LLC

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Mucinex®DM

Drug Facts

Active ingredients (in each extended-release bi-layer tablet)Purposes
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: 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 ®

20
EXTENDED-RELEASE
BI-LAYER TABLETS

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton
MUCINEX DM 
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)  
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: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
11NDC:63824-056-802 in 1 CARTON05/01/2024
1120 in 1 BLISTER PACK; 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)

Revised: 6/2024
Document Id: 1bbd6ebf-317b-f675-e063-6394a90a2430
Set id: 70987d06-d206-445f-bd0d-5e1345b8465c
Version: 16
Effective Time: 20240625
 
RB Health (US) LLC