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SIMPEX Guaifenesin

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

Drug Facts


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 with excessive 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 care 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 & 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
  • preserve in tight containers at a temperature not exceeding 30°C.

Inactive ingredients

colloidal anhydrous silica, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinised starch, sodium starch glycolate type A, stearic acid

Package Labeling:

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
SILICON DIOXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
POVIDONE 
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 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIOperations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-004)

 
Simpex Pharma Pvt. Ltd

Medically reviewed on Feb 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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