MUCUS RELIEF DM EXPECTORANT AND COUGH SUPPRESSANT- dextromethorphan hydrobromide and guaifenesin tablet, coated 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each tablet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purpose

Cough suppressant

Expectorant

Uses

  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

Warnings

Do not use 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

  • cough accompanied with excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied with fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care 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

  • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years of age: do not use

Other information

  • each tablet contains: sodium 20 mg LOW SODIUM
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • keep in a dry place and do not expose to excessive heat

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate and stearic acid

Questions or comments?

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

Principal Display Panel

IMMEDIATE ACTING

Mucus Relief DM

EXPECTORANT / COUGH SUPPRESSANT

400 mg Guaifenesin and 20 mg Dextromethorphan HBr

  • Soothes Cough
  • Loosens Congestion

TABLETS

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

Product Label

Guaifenesin 400 mg, Dextromethorphan HBr 20 mg

Assured Mucus Relief DM

 

MUCUS RELIEF DM  EXPECTORANT AND COUGH SUPPRESSANT
dextromethorphan hydrobromide and guaifenesin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize12mm
FlavorImprint Code TCL280;G2;G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0109-11 in 1 BOX01/06/201004/30/2018
115 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/06/201004/30/2018
Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)

Revised: 10/2016
Document Id: 58ee4ba9-a7d4-4786-9721-2fa24468ed15
Set id: 28dba363-6c99-4f87-a78d-5d7abbf76a5c
Version: 2
Effective Time: 20161026
 
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)