STOOL SOFTENER- docusate sodium capsule, liquid filled 
Chain Drug Consortium, LLC

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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pv 401

Active ingredient (in each softgel)

Docusate Sodium 100 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

• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD&C red #40, gelatin,
glycerin, edible ink, PEG, propylene glycol, sorbitol
special, water. May also contain D&C yellow #10,
FD&C yellow #6 (sunset yellow), mannitol.

Package Label

pv 401

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-401
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 401
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-401-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
2NDC:68016-401-25250 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
3NDC:68016-401-0660 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/201212/01/2021
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIBusiness Operations
Geri-Care Pharmaceutical Corp611196254repack(68016-401)

Revised: 12/2020
 
Chain Drug Consortium, LLC