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STOOL SOFTENER EXTRA STRENGTH by Atlantic Biologicals Corps

Medically reviewed on November 9, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Atlantic Biologicals Corps
NDC Code: 17856-0443

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.

Drug Facts

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.

Warnings - 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

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
  • take 1 softgel daily or as directed by a doctor adults and children over 12 years of age and over:
  • : take as directed by a doctor children under 12 years of age

Other information
  • sodium 15 mg each softgel contains:
  • store at controlled room temperature 15 - 30 C (59 - 86 F) oooo
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free 1-877-753-3935

STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED
STOOL SOFTENER   EXTRA STRENGTH
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0443(NDC:24385-443)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 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
ShapeCAPSULESize20mm
FlavorImprint CodeP20
Contains    
Packaging
#Item CodePackage Description
1NDC:17856-0443-11 CAPSULE, LIQUID FILLED (1 CAPSULE) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/09/2010
Labeler - Atlantic Biologicals Corps (047437707)
Registrant - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIOperations
Atlantic Biologicals Corps047437707RELABEL(17856-0443), REPACK(17856-0443)

 
Atlantic Biologicals Corps

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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