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Guaifenesin by Physicians Total Care, Inc.

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5847

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 PanelThe product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.
NDC 54868-5847-0


GUAIFENESIN TABLETS
Guaifenesin 200 mg
Expectorant
  • Relieves Chest Congestion
  • Thins and Loosens Mucus
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 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 Code44;588
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-5847-01 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON
1100 TABLET (100 TABLET) 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/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 03/2012
 
Physicians Total Care, 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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