Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 92f2147d-b52d-4282-b217-28f6095dca0e
Route
ORAL
Published
Effective Date 2025-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (100 mg)
Inactive Ingredients
Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-31
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 women, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for a period longer than 1 week unless directed by a doctor
Package Label
EQUATE Mineral Oil
Active Ingredient

Mineral oil 100%

Other Information
  • keep tightly closes
  • protect from direct light
Inactive Ingredients

Vitamin E as stabilizer

Questions Or Comments?

Call 1-888-287-1915

Principal Display Panel

Mineral Oil

Lubricant Laxative

  • Odorless
  • Tasteless
  • Colorless

FL OZ (mL)

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

Distributed by Wal-Mart Inc.,

Bentonville, AR 72716

When Using This Product
  • do not take with meals
  • take only at bedtime
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.

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.

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.

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

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 women, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for a period longer than 1 week unless directed by a doctor
Package Label
EQUATE Mineral Oil
Active Ingredient (Active ingredient)

Mineral oil 100%

Other Information (Other information)
  • keep tightly closes
  • protect from direct light
Inactive Ingredients (Inactive ingredients)

Vitamin E as stabilizer

Questions Or Comments? (Questions or comments?)

Call 1-888-287-1915

Principal Display Panel

Mineral Oil

Lubricant Laxative

  • Odorless
  • Tasteless
  • Colorless

FL OZ (mL)

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

Distributed by Wal-Mart Inc.,

Bentonville, AR 72716

When Using This Product (When using this product)
  • do not take with meals
  • take only at bedtime
Stop Use and Ask A Doctor If (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.

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.

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.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:31.707807 · Updated: 2026-03-14T23:09:21.323328