MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release 
Preferred Pharmaceuticals Inc.

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Mucinex®DM

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

EXPECTORANT & COUGH SUPPRESSANT

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

•
tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
•
store between 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.

Distributed by:
Reckitt Benckiser
Parsippany, NJ 07054-0224

Made in England

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 20 Tablet Carton

NDC 68788-6340-2

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

EXPECTORANT & COUGH SUPPRESSANT

12
HOUR

1.
Controls Cough
2.
Thins and Loosens Mucus
3.
Immediate and Extended Release

20
EXTENDED-RELEASE
BI-LAYER TABLETS

Repackaged By: Preferred Pharmaceuticals Inc.

Mucinex DM
MUCINEX DM 
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6340(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)  
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:68788-6340-21 in 1 CARTON10/17/201608/02/2021
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02162010/17/201608/02/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6340)

Revised: 8/2021
Document Id: a2a6901a-d843-4681-805f-cb97cf6a0da7
Set id: 2d545c6f-30bf-4806-ada4-bbe55fe4625f
Version: 7
Effective Time: 20210802
 
Preferred Pharmaceuticals Inc.