Your browser does not support JavaScript! FLEET (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [C.B. FLEET COMPANY, INC.]
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RxNorm Names

FLEET (docusate sodium) capsule, gelatin coated
[C.B. Fleet Company, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg..............Stool Softener

Uses

  • for the prevention of dry, hard stools
  • for relief of occasional constipation

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 right away.

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 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 symptoms may indicate a serious condition.

Directions

Single Daily Dosage

adults and children 12 years and over
1 - 3 softgels
children 2 to under 12 years
1 softgel
children under 2 years
ask a doctor

Other Information

  • each softgel contains: sodium 5 mg
  • this product generally produces a bowel movement within 12 to 72 hours
  • mouth of bottle sealed for your safety. If foil impirinted "SEALED FOR YOUR PROTECTION" is broken or missing, do not use

Inactive Ingredients

edible white ink, FDandC red 40, FDandC yellow 6, gelatin, glycerin, mannitol, polyethylene glycol, polysorbate, propylene glycol, purified water and sorbitol

Questions?

1-866-255-6960 or www.fleetlabs.com

image of label

FLEET 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0132-0751
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg  in 60 
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
MANNITOL 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
POLYSORBATE 20 
Product Characteristics
Colorred (Clear, Bright Red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0751-6060 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/30/2002
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
PL Development800014821manufacture(0132-0751)

Revised: 2/2013
 
C.B. Fleet Company, Inc.

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