FLEET- mineral oil liquid

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 5 mL/teaspoonful)

Mineral Oil 2.5 mL.......................................

Purpose

Lubricant Laxative

Uses

▪ relieves occasional constipation

▪ generally produces bowel movement in 6 to 8 hours

Warnings

Do not use

▪ for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing

Ask a doctor before using this product if you have

▪ abdominal pain, nausea or vomiting

▪ a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking a stool softener laxative.

When using this product

do not take with meals.

Stop use and ask a doctor if

▪ you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.

▪ you need to use the product more than one week

If breast-feeding,

ask a health professional before use. 

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

▪ do not take with meals

▪ shake well before using

▪ adults and children 12 years of age and over: 3 to 9 teaspoons  (15 - 45 mL), maximum 9 teaspoons (45 mL) in 24 hours

▪ children 6 to under 12 years of age: 1 to 3 teaspoons (5 – 15 mL), maximum 3 teaspoons (15 mL) in 24 hours or as directed by a doctor

▪ children under 6 years of age: consult a doctor

Inactive ingredients

acacia, benzoic acid, carrageenan (irish moss), ethyl vanillin, glycerin, mapliene triple oil, purified water, titanium dioxide, vanillin

Other information

Store at room temperature 15°-25°C (59°-77°F)

Questions?

Call toll-free 1-855-727-4277

Principal Display Panel

Fleet ® 
Laxative
Mineral Oil
Oral Liquid
Lubricant Laxative

16 FL OZ (480 mL)

INGREDIENTS AND APPEARANCE

FLEET 
mineral oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0400
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	2.5 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ETHYL VANILLIN (UNII: YC9ST449YJ)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
VANILLIN (UNII: CHI530446X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0400-48	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/01/2024

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