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.

----------

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

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

Place holder

image of carton

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.

FLEET
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0132-0301
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (Mineral Oil)	Mineral Oil	118 mL in 118 mL

Packaging
#	Item Code	Package Description
1	NDC:0132-0301-40	1 in 1 CARTON
1		133 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/01/2002

Labeler - C.B. Fleet Company, Inc. (003119054)

Establishment
Name	Address	ID/FEI	Business Operations
C.B. Fleet Company, Inc.		003119054	manufacture

Revised: 04/2011

Document Id: c77e7312-4e2f-4c23-bb3d-9ab46d36dc65

Set id: 2528cb5e-437e-41f0-9c34-e9ce57404d8b

Version: 5

Effective Time: 20110411

C.B. Fleet Company, Inc.