Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID 0dd5380e-9671-4a2b-a2ce-6477503d06d2

Routes

ORAL TOPICAL

Published

Effective Date 2025-04-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Mineral Oil (100 mg)

Inactive Ingredients

Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-11-30

Description

Mineral Oil 100%

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Mineral Oil 100%

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours

Directions

do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses
adults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL
children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL
children under 6 years, consult a doctor

Do Not Use

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
if you are presently taking a stool softener laxative
for longer than 1 week

Package Label

TOPCARE HEALTH Mineral Oil

Active Ingredient

Mineral Oil 100%

Other Information

keep tightly closed
protect from direct light

Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

LUBRICANT LAXATIVE

For Relief of Occasional Constipation
Odorless
Tasteless
Colorless

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

Questions or comments? Call toll free 1-888-423-0139

When Using This Product

do not take with meals
take only at bedtime

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product

Ask A Doctor Before Use If You Have

abdominal pain, nausea or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use and Ask A Doctor If You Have

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours

Purpose

Lubricant laxative

Directions

do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses
adults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL
children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL
children under 6 years, consult a doctor

Do Not Use (Do not use)

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
if you are presently taking a stool softener laxative
for longer than 1 week

Package Label

TOPCARE HEALTH Mineral Oil

Active Ingredient

Mineral Oil 100%

Other Information

keep tightly closed
protect from direct light

Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

LUBRICANT LAXATIVE

For Relief of Occasional Constipation
Odorless
Tasteless
Colorless

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

Questions or comments? Call toll free 1-888-423-0139

When Using This Product (When using this product)

do not take with meals
take only at bedtime

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 (1-800-222-1222) right away.

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

ask a health professional before use. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

abdominal pain, nausea or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use and Ask A Doctor If You Have (Stop use and ask a doctor if you have)

rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours", "Purpose": "Lubricant laxative", "Directions": "do not take with meals take only at bedtime may be taken as a single daily dose or in divided doses adults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL children under 6 years, consult a doctor ", "Do not use": "in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week", "Package Label": "TOPCARE HEALTH Mineral Oil ", "Active Ingredient": "Mineral Oil 100%", "Other Information": "keep tightly closed protect from direct light", "Inactive Ingredient": "Vitamin E as stabilizer", "Principal Display Panel": "Mineral Oil LUBRICANT LAXATIVE For Relief of Occasional Constipation Odorless Tasteless Colorless FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 Questions or comments? Call toll free 1-888-423-0139", "When using this product": "do not take with meals take only at bedtime", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.", "If pregnant or breast feeding,": "ask a health professional before use. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product", "Ask a doctor before use if you have": "abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks", "Stop use and ask a doctor if you have": "rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:58.766463 · Updated: 2026-03-14T23:08:25.015175