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Docusate Sodium by Geri-Care Pharmaceutical Corp

Medically reviewed on December 25, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Geri-Care Pharmaceutical Corp
NDC Code: 57896-425

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.

gc425

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

  • have stomach pain, nausea, or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
  • are presently taking mineral oil

Stop use and ask a doctor if

  • you need to use a laxative longer than 1 week
  • you have rectal bleeding or fail to have a bowel movement.

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
  • follow directions below or as directed by your physician
  • do not exceed recommended dose
Adults and children 12 years of age and olderTake one softgel daily
children under 12Do not use

Other information
  • each softgel contains: sodium 15 mg
  • store at room temperature, 15°-30°C (59°-86°F)
  • product of Canada
  • Package not child resistant
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, propylene glycol, sorbitol sorbitan solution, water

package Label

DOCUSATE SODIUM 
stool softener capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-425
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)  
GELATIN 
GLYCERIN 
SORBITOL 
SORBITAN 
WATER 
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
Product Characteristics
ColorredScoreno score
ShapeOVAL (capsule) Size23mm
FlavorImprint CodeGC425
Contains    
Packaging
#Item CodePackage Description
1NDC:57896-425-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2016
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

 
Geri-Care Pharmaceutical Corp

← See all Docusate Sodium brands

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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