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SIMPEX Guaifenesin

Medically reviewed on November 7, 2017

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: Simpex Pharma Pvt. Ltd
NDC Code: 76457-004

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.

SIMPEX Guaifenesin

SIMPEX Guaifenesin


Active ingredient (in each tablet)

Guaifenesin 400 mg

Purpose

Expectorant

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

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, recurs, or is accompanied 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
  • adults and children 12 years of age and older: take a tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years of age: do not use.

Other information
  • store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
  • do not use if blister foil is broken
  • retain carton for complete product information

Inactive ingredients

  • colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate and stearic acid.

Questions or comments?

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SIMPEX Guaifenesin 400mg Tablets (76457-004-00)


SIMPEX GUAIFENESIN  
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
Colorred (Iron oxide red, Iron oxide yellow) Scoreno score
ShapeROUND (Biconvex) Size6mm
FlavorImprint Code;
Contains    
Packaging
#Item CodePackage Description
1NDC:76457-004-00100 TABLET (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/07/2013
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIOperations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-004)

 
Simpex Pharma Pvt. Ltd

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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