Major 44-533

Major 44-533

Drug Labeling and Warnings

Drug Details

k">

MUCUS RELIEF DM COUGH- dextromethorphan hbr, guaifenesin tablet, film coated 
Major Pharmaceuticals

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

  • 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 associated with the common cold
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

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 by too much 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.

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use 

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

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

Questions or comments?

(800)616-2471

Principal Display Panel

MAJOR®

NDC: 0904-6816-52

MucusRelief
DM COUGH

Dextromethorphan HBr, 20 mg
Guaifenesin, 400 mg

Cough Suppressant
Expectorant

Controls Cough
Thins and Loosens Mucus

Immediate Release

60 Tablets

Actual Size

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

Distributed by: MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA

Rev. 09/18    M-17   Re-order No. 701016

Major 44-533

Major 44-533

MUCUS RELIEF DM COUGH 
dextromethorphan hbr, guaifenesin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0904-6816
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize16mm
FlavorImprint Code 44;533
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0904-6816-4630 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2018
2NDC: 0904-6816-5260 in 1 BOTTLE; Type 0: Not a Combination Product12/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/19/2018
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0904-6816)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0904-6816)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0904-6816)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0904-6816)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0904-6816)

Revised: 1/2019
 
Major Pharmaceuticals


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.