MUCUS DM EXTENDED-RELEASE- dextromethorphan hydrobromide and guaifenesin tablet 
P & L Development, LLC

----------

Drug Facts

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purpose

Cough suppressant

Expectorant

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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

maximum strength

Mucus relief DM

guaifenesin 1200 mg expectorant

dextromethorphan HBr 60 mg cough suppressant

extended-release tablets

*Compare to the active ingredients in Maximum Strength Mucinex® DM

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Maximum Strength Mucinex® DM.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Package Label

Dextromethorphan HBr 60 mg, Guaifenesin 1200 mg

WELLNESS BASICS Maximum Strength Mucus Relief DM

MUCUS DM EXTENDED-RELEASE 
dextromethorphan hydrobromide and guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-834
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CARBOMER 934 (UNII: Z135WT9208)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize22mm
FlavorImprint Code AN039
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-834-1414 in 1 CARTON01/01/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20969201/01/2019
Labeler - P & L Development, LLC (800014821)

Revised: 12/2019
Document Id: b4df16e9-d913-4d5b-820b-213bf32445e7
Set id: 3278b3a1-b11d-4ae6-bef9-f956a950fb2d
Version: 3
Effective Time: 20191206
 
P & L Development, LLC