STOOL SOFTENER- docusate sodium capsule, liquid filled 
PHARMACY VALUE ALLIANCE, LLC

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401S PVA

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

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

or as directed by a doctor.

Other information

each softgel contains: sodium 7 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

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Package Label

1

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-257
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 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
Colorred (reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-257-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
2NDC:68016-257-25250 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00710/01/2022
Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023
Document Id: 08175e5f-e027-25be-e063-6394a90a2a31
Set id: f06e5244-0842-743e-e053-2a95a90afad0
Version: 3
Effective Time: 20231019
 
PHARMACY VALUE ALLIANCE, LLC