Fleet Mineral Oil 0132-0301-40

SPL v14

SPL

SPL Set ID 2528cb5e-437e-41f0-9c34-e9ce57404d8b

Route

RECTAL

Published

Effective Date 2023-10-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (100 g)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2002-05-01

Description

Drug Facts

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Drug Facts

Fleet _®

Laxative

Mineral Oil enema

lubricant laxative

1 bottle - 4.5 FL OZ (133 mL)

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.

Section 42229-5

Drug Facts

Warnings

For rectal use only .

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

Do Not Use

when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

1-866-255-6960 or www.fleetlabs.com

Other Information

sodium-free

Inactive ingredients

none

Active Ingredient (in Each 118

Mineral oil 100%

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.

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.

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

Structured Label Content

Fleet _®

Laxative

Mineral Oil enema

lubricant laxative

1 bottle - 4.5 FL OZ (133 mL)

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.

Section 42229-5 (42229-5)

Drug Facts

Purpose

Lubricant laxative

Warnings

For rectal use only .

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

Do Not Use (Do not use)

when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Questions?

1-866-255-6960 or www.fleetlabs.com

Other Information (Other information)

sodium-free

Inactive ingredients (Inactive Ingredients)

none

Active Ingredient (in Each 118 (Active ingredient (in each 118)

Mineral oil 100%

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If You Have (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.

Ask A Doctor Before Using This Product If You (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

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"P": "Fleet ® Laxative Mineral Oil enema lubricant laxative 1 bottle - 4.5 FL OZ (133 mL)", "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.", "42229-5": "Drug Facts", "Purpose": "Lubricant laxative", "Warnings": "For rectal use only .", "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", "Do not use": "when abdominal pain, nausea, or vomiting are present unless directed by a doctor.", "Questions?": "1 -866-255-6960 or www.fleetlabs.com", "Other information": "sodium-free", "Inactive Ingredients": "none", "Active ingredient (in each 118": "Mineral oil 100%", "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.", "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.", "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"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:42.597675 · Updated: 2026-03-14T23:01:28.904310