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

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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SPL UNCLASSIFIED SECTION

Fleet Mineral Oil

Drug Facts

Active ingredient

Mineral oil (Heavy) 130 mL

Purpose

Lubricant laxative

Uses

• relieves occasional constipation
  
• softens the stool

Warnings

Do not use

with any other laxative.

Ask a doctor or pharmacist before use if you have 

• abdominal pain
  
• nausea or vomiting
  
• fever
  
• noticed a sudden change in bowel habits lasting for longer than 2 weeks
  
• are pregnant or breastfeeding

When using this product

• do not take it within 2 hours of other medicines
  
• it may take 2 to 15 minutes to have a bowel movement
  
• overuse or extended use may cause dependence for bowel function

Stop use and ask a doctor if

• rectal bleeding occurs
  
• symptoms last for more than 7 days.

This may be a sign of serious condition.

Inactive

• None

Other warnings 

• overuse or extended use may cause dependence for bowel function
  
• do not give to infants or children under 12 years, or to bedridden or aged patients, unless directed by a doctor

Keep out of reach of children.

In case of overdose, call a poison control centre or get medical help right away.

Directions

• Adults and children 12 years and older; take 120 mL as a single dose
  
• Do not take more than 120 mL in 24 hours

Other information

store at room temperature

Questions?

Call 1-866-255-6960 

PRINCIPAL DISPLAY PANEL

Fleet®

Mineral Oil
Enema

130 mL

INGREDIENTS AND APPEARANCE

FLEET 
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0556
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: 0132-0556-40	130 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 Drug	M007	05/01/2002

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