Fleet Mineral Oil 0132-0400

Fleet Mineral Oil 0132-0400
SPL v1
SPL
SPL Set ID e0b7acab-add4-4daf-b1df-bb7cf5ca8e19
Route
ORAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (2.5 g)
Inactive Ingredients
Acacia Benzoic Acid Carrageenan Ethyl Vanillin Glycerin Water Titanium Dioxide Vanillin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Drug Facts

Purpose

Lubricant Laxative


Medication Information

Purpose

Lubricant Laxative

Description

Drug Facts

Uses

▪ relieves occasional constipation

▪ generally produces bowel movement in 6 to 8 hours

Section 42229-5

Drug Facts

Inactive

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

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

Do Not Use

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

Questions?

Call toll-free 1-855-727- 4277

Other Information

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

If Breast Feeding,

ask a health professional before use. 

Principal Display Panel

Fleet ®  

Laxative

Mineral Oil

Oral Liquid

Lubricant Laxative

16 FL OZ (480 mL)

When Using This Product

do not take with meals.

Active Ingredient (in Each

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

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

Keep Out of Reach of Children.

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

Ask A Doctor Before Using This Product If You

▪ 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.


Structured Label Content

Uses

▪ relieves occasional constipation

▪ generally produces bowel movement in 6 to 8 hours

Section 42229-5 (42229-5)

Drug Facts

Purpose

Lubricant Laxative

Inactive

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

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

Do Not Use (Do not use)

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

Questions?

Call toll-free 1-855-727- 4277

Other Information (Other information)

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

If Breast Feeding, (If breast-feeding,)

ask a health professional before use. 

Principal Display Panel

Fleet ®  

Laxative

Mineral Oil

Oral Liquid

Lubricant Laxative

16 FL OZ (480 mL)

When Using This Product (When using this product)

do not take with meals.

Active Ingredient (in Each (Active ingredient (in each)

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

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Using This Product If You (Ask a doctor before using this product if you)

▪ 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 (Ask a doctor or pharmacist before use if you are)

presently taking a stool softener laxative.


Advanced Ingredient Data


Raw Label Data

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