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DOCUSATE SODIUM by J.P. BUSINESS ENTERPRISE

Medically reviewed on November 17, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: J.P. BUSINESS ENTERPRISE
NDC Code: 59105-007

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.

DOCUSATE SODIUM SOFTGEL CAPSULES 100MG

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses
  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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
  • take with a glass of water
adults and children 12 years of age and overtake 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years of ageconsult a physician

Other information
  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

Questions or comments?

Call toll free: 1-888-333-9792

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

PRINCIPAL DISPLAY PANEL - 50 Softgel Bottle Carton

VALUMEDS

Compare to the active ingredient in
Dulcolax® Stool Softener

STOOL SOFTENER
DOCUSATE SODIUM 100 MG

  • GENTLE RELIEF
  • EFFECTIVE
  • STIMULANT FREE

50 SOFTGELS

DOCUSATE SODIUM  
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59105-007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
GELATIN 
GLYCERIN 
SORBITOL 
FD&C RED NO. 40 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize10mm
FlavorImprint Code125
Contains    
Packaging
#Item CodePackage Description
1NDC:59105-007-501 BOTTLE in 1 CARTON
150 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/2014
Labeler - J.P. BUSINESS ENTERPRISE (078775890)
Establishment
NameAddressID/FEIOperations
MEDGEL PVT LTD677385498MANUFACTURE(59105-007)

 
J.P. BUSINESS ENTERPRISE

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Further information

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

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