GUAIFENESIN- 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.

----------

Active ingredient (in each immediate-release tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Use(s)

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

Warnings

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)

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 to 2 tablets every
4 hours
children 6 to under 12 years
of age 

½ to 1 tablet every

4 hours 
children under 6 years of age consult a physician 

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions?

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

Principal Display Panel

The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.
NDC 0904-5154-60MAJOR®
GUAIFENESINTABLETSGuaifenesin 200 mg
Expectorant
  • Relieves Chest Congestion
  • Thins and Loosens Mucus
100 TabletsImmediate Release50844     REV0510A58812Distributed by MAJOR PHARMACEUTICALS31788 Enterprise Drive, Livonia, MI 48150 USARe-Order No. 238163        M-17        Rev. 11/10TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Product Packaging

Product Packaging


GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5154
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;588
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5154-601 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/05/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 03/2011
Document Id: 2d20b861-ac5d-4b2d-99a4-f5f2e6b9a16e
Set id: aa662428-e61f-4e22-af4d-8cf63df68c99
Version: 10
Effective Time: 20110314
 
Major Pharmaceuticals