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Stool Softener by Chain Drug Consortium, LLC

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-401

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.

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

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-401
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
WATER 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MANNITOL 
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code401
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-401-01100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:68016-401-25250 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:68016-401-0660 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
NameAddressID/FEIOperations
Geri-Care Pharmaceutical Corp611196254repack(68016-401)

 
Chain Drug Consortium, LLC

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Medically reviewed on Jan 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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