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Guaifenesin by Contract Pharmacy Services-PA

Dosage form: tablet
Ingredients: GUAIFENESIN 200mg
Labeler: Contract Pharmacy Services-PA
NDC Code: 67046-251

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.

Guaifenesin

Drug Facts

Active Ingredient (in each immediate-release tablet)

Guaifenesin 200 mg

Purpose

Guaifenesin, USP                               Expectorant

Uses

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 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 over1 to 2 tablets every 4 hours
children 6 to under 12 years of age1/2 to 1 tablet every 4 hours
children under 6 years of ageconsult a physician

Other Information
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients

Silicon Dioxide, FD&C Red No. 40, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid.

Questions?

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

Distributed by

Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--1/2011--NJW

Package Label

Blister of 30 Tablets

GUAIFENESIN 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-251(NDC:0904-5154)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code44;588
Contains    
Packaging
#Item CodePackage Description
1NDC:67046-251-3030 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/27/2011
Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 09/2010
 
Contract Pharmacy Services-PA

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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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