DOCUSATE SODIUM- stool softener capsule, liquid filled 
Geri-Care Pharmaceutical Corp

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.

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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

G

DOCUSATE SODIUM 
stool softener capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-425
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (capsule) Size23mm
FlavorImprint Code GC425
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-425-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/201604/01/2021
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2020
 
Geri-Care Pharmaceutical Corp