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EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 250mg in 250mg
Labeler: Aidapak Services, LLC
NDC Code: 52327-011

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.

Docusate Sodium 250mg - Relabeled Product

Active Ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Uses:

•for the prevention of dry, hard stools

•for relief of occasional constipation

•this product generally produces a bowel movement within 12 to 72 hours.

Do not use

•if you are currently taking mineral oil, unless directed by a doctor

•when abdominal pain, nausea, or

vomiting are present

•for more than 1 week, unless directed by a doctor.

Ask a doctor before use if:

•you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if:

•you have rectal bleeding

•you fail to have a bowel movement after use. These could be signs of a serious condition.

•ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Directions:

Adults and children 12 years of age and over:

take 1 softgel daily or as directed by a doctor.

Children under 12 years of age: take as directed by doctor.

Other Information:

each softgel contains: sodium 15 mg.

Store between 15-30 C (59-86 F)

edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52327-011(NDC:0536-3757)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg  in 250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColororangeScoreno score
ShapeOVALSize20mm
FlavorImprint CodeP20
Contains    
Packaging
#Item CodePackage Description
1NDC:52327-011-11100 BLISTER PACK in 1 BLISTER PACK
1NDC:52327-011-101 mg in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/20/2014
Labeler - Aidapak Services, LLC (831612457)
Registrant - Aidapak Services, LLC (831612457)
Establishment
NameAddressID/FEIOperations
Aidapak Services, LLC831612457relabel(52327-011)

 
Aidapak Services, LLC

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Medically reviewed on Oct 10, 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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