ENEMEEZ STOOL SOFTENER- docusate sodium capsule, liquid filled 
Enemeez Inc.

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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Docusate Sodium Stool Softener

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • for the relief of occasional constipation.
  • helps to prevent dry, hard stools.
  • 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 longer than one week unless directed by a doctor.

Ask a doctor before use

if you notice a sudden change in bowel habits that persist over a period of two weeks

Stop use and ask a doctor if:

  • you have rectal bleeding.
  • you fail to have a bowel movement after use.

 If you are pregnant or breast-feeding,

ask a healthcare 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 over
  • Take orally 1 to 2 softgels preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children 6 to 12 years of age
  • Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 6 years of age
  • Do not use this product for children under 6 years of age, unless directed by a doctor.

Other Information

  • each softgel contains : sodium 5 mg of sodium.
  • Keep lid tightly closed.
  • Store at room temperature between 15 - 25 degrees C (59 - 77 degrees F).
  • do not use if imprinted safety seal under cap is broken or missing.
  • For identification purposes, each softgel will have an imprint that reads NV13.

Inactive Ingredients

FD C Red No. 40, FD C Yellow No. 6, gelatin, glycerin,Ink (edible), Polyethylene glycol, propylene glycol, purified water, sorbitol.

Product Label

Docusate Sodium USP

ENEMEEZ STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9882
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code NV13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17433-9882-1100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/201307/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/29/201307/29/2016
Labeler - Enemeez Inc. (010717819)
Registrant - Enemeez Inc. (010717819)
Establishment
NameAddressID/FEIBusiness Operations
National Vitamin Company102098324manufacture(17433-9882)

Revised: 12/2017
 
Enemeez Inc.