FLEET- mineral oil enema 
C.B. Fleet Company, 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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Fleet Mineral Oil

Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

This product usually produces a bowel movement in 2 to 15 minutes.

Warnings

For rectal use only

Do not use

when abdominal pain, nausea, or vomiting are present unless directed by a doctor

Ask a doctor before using this product if you

  • have 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 within 15 minutes of using this product

These symptoms may indicate a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

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

Directions

Single Daily Dosage (per 24 hours)

adults and children
12 years and over
1 bottle per day
children
2 to under 12 years
one-half bottle
children
under 2 years
DO NOT USE

Other information

Questions?

1-866-255-6960 or www.fleetlabs.com

PRINCIPAL DISPLAY PANEL

Fleet®

Mineral Oil
enema

lubricant laxative

1 bottle - 4.5 FL OZ (133 mL)

Fleet®
Mineral Oil 
enema
lubricant laxative
1 bottle - 4.5 FL OZ (133 mL)

FLEET 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0301
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0301-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2002
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)

Revised: 1/2021
Document Id: e6c89af1-7321-46b6-aaf2-140f28283c1f
Set id: 2528cb5e-437e-41f0-9c34-e9ce57404d8b
Version: 11
Effective Time: 20210114
 
C.B. Fleet Company, Inc.