Your browser does not support JavaScript! FLEET (MINERAL OIL) ENEMA [C.B. FLEET COMPANY, INC.]
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RxNorm Names

FLEET (mineral oil) enema
[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 118-mL delivered dose)

Mineral Oil 100% ......Lubricant Laxative

Uses

  • for relief of fecal impaction
  • for relief of occasional constipation
  • for removal of residue after barium administration

Warnings

For rectal use only.

If pregnant or breast-feeding ask a health professional before use.

Directions

Single daily dose

adults and children 12 years and over
1 bottle


children 2 to under 12 years
one-half bottle


children under 2 years
DO NOT USE

Other Information

Other Information

  • sodium free
  • this product generally produces a bowel movement in 2-15 minutes
  • carton sealed for safety. If seal with Fleet emblem on top or bottom flap is missing, do not use
  • consult Physicians' Desk Reference for complete professional labeling

Questions?

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

Ask a doctor before using any laxative if you have

  • abdominal pain, nausea or vomiting 
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop use and ask a doctor if you have

  • rectal bleeding
  • no bowel movement after use

These symptoms may indicate a serious condition.

Keep out of reach of children


If swallowed, get medical help or contact a Poison Control Center right away.

image description

FLEET 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0132-0301
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (Mineral Oil) Mineral Oil118 mL  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0301-40133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2002
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
C.B. Fleet Company, Inc.003119054manufacture(0132-0301)

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

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