MUCUS RELIEF- guaifenesin tablet 
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.

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Major 44-532-Delisted

Active ingredient(s)

 Guaifenesin 400 mg

Purpose

 Expectorant

Use(s)

 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema 

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 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 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 controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1 alluminum lake, 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

NDC 0904-5758-46

MAJOR®

MucusRelief

Guaifenesin 400 mg

Expectorant

• Alleviates Chest Congestion

• Loosens Mucus

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

50844     REV0510E53201    M-17

Distributed by Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

Re-order No. 100264        Rev. 10/10

Product Packaging
MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5758
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code 44;532
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5758-011 in 1 CARTON
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/22/200511/04/2018
Labeler - Major Pharmaceuticals (191427277)

Revised: 11/2015
Document Id: a8123548-48a7-4b2d-9d19-74388b11ad95
Set id: 71cf1f30-4dbc-46c4-b40b-2a68deb362b5
Version: 7
Effective Time: 20151116
 
Major Pharmaceuticals