STOOL SOFTENER- docusate sodium capsule, liquid filled 
Geri-Care Pharmaceutical Corp

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gc 401

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts for over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement.

These could be signs of a serious condition.

• you need to use a laxative for longer than 1 week

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

Other information

each softgel contains: sodium 5 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, PEG, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink.

Questions or comments?

1-800-540-3765

Package Label

1

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint Code PC1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-411-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
2NDC:57896-411-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/01/2024
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 2/2024
Document Id: 1057c096-a5cb-248c-e063-6394a90a76b7
Set id: 1057c0bf-4bf6-ea17-e063-6294a90a5984
Version: 1
Effective Time: 20240201
 
Geri-Care Pharmaceutical Corp