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Mucus Relief DM by Preferred Pharmaceuticals, Inc.

Dosage form: tablet, film coated
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg, GUAIFENESIN 400mg
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-0839

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.

Major 44-533

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

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

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
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 exceed 6 doses in 24 hours
take with a full glass of water
adults and children 12 years of age and over: 1 tablet, every 4 hours
children under 12 years: do not use

Other information
store at controlled room temperature 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

D&C yellow #10, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions?

 To Report Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

MAJOR®

NDC 68788-0839

Mucus Relief DM
Guaifenesin 400 mg
Dextromethorphan HBr 20 mg

Expectorant
Cough Suppressant

Alleviates Chest Congestion

Reduces Cough

500 Tablets

Immediate Release

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

50844    REV1108B53314  M-17
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA 
Rev. 10/09
Re-order No. 100408

Repackaged By: Preferred Pharmaceuticals Inc.

Major 44-533

MUCUS RELIEF DM 
dextromethorphan hbr and guiafenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0839(NDC:0904-6013)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorYELLOWScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code44;533
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-0839-220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:68788-0839-330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3NDC:68788-0839-660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/12/2009
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0839)

Revised: 12/2017
 
Preferred Pharmaceuticals, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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