GUAIFENESIN - guaifenesin tablet 
Physicians Total Care, 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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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

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

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 54868-5847-0
Product Packaging


GUAIFENESIN TABLETS
Guaifenesin 200 mg
Expectorant 100 Tablets Immediate Release

50844     REV0510A58812

Distributed by MAJOR PHARMACEUTICALS
31788 Enterprise Drive,
Livonia, MI 48150 USA
Re-Order No. 238163        M-17        Rev. 11/10
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5847(NDC:0904-5154)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;588
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5847-01 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/07/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 3/2012
Document Id: 90123dd1-81e6-42b2-ac2e-c5bae2ed20f7
Set id: bf32f7e3-2973-434a-a3c5-7e40bedf5f2a
Version: 1
Effective Time: 20120301
 
Physicians Total Care, Inc.