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Stool Softener by TOP CARE (Topco Associates LLC)

Medically reviewed on June 5, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-007

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 100 mg

Purpose

Stool softener

Uses
  • temporary relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use
  • if abdominal pain, nausea, or vomiting are present

Ask a doctor before use if
  • you notice a sudden change in bowel habits that persists over a period of 2 weeks
  • you are presently taking mineral oil

Stop use and ask a doctor if
  • rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions
  • take with a glass of water
 adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
 children 2 to under 12 years of age take 1 softgel daily 
 children under 2 years of age  ask a doctor

Other information
  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

GENTLE RELIEF

Stool Softener

DOCUSATE SODIUM 100 mg

  • Fast, Dependable Relief of Occasional Constipation

COMPARE TO DULCOLAX® active ingredient*

SOFTGELS

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

Package Label

Top Care Stool Softener Softgel

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-007
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 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize13mm
FlavorImprint CodeP51
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-007-251 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
125 CAPSULE, LIQUID FILLED (25 CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/31/2013
Labeler - TOP CARE (Topco Associates LLC) (006935977)
Registrant - P and L Development of New York Corporation (800014821)

 
TOP CARE (Topco Associates LLC)

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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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