FLEET- mineral oil enema

FLEET by

Drug Labeling and Warnings

FLEET by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

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

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

• sodium-free
  
• for complete Professional Use, Warnings and Precautions, consult the Reference Safety Information on our website

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)

INGREDIENTS AND APPEARANCE

FLEET 
mineral oil enema

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	100 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0301-40	133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/01/2002

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)