Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 581f81a0-7488-4c90-b33e-06c6301a4fd2
Routes
ORAL TOPICAL
Published
Effective Date 2025-04-17
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 2016-11-30
Description

Mineral Oil, USP 100%

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Mineral Oil, USP 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 minimum 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 of age: 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

GOOD NEIGHBOR PHARMACY Mineral Oil
 

Active Ingredient

Mineral Oil, USP 100%

Other Information
  • keep tightly closed
  • protect from direct light
Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

SAFETY SEALED

Mineral Oil

Lubricant Laxative

Odorless-Tasteless

Crystal Clear

FL OZ (mL)

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

Distributed by AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

www.mygnp.com

Questions or comments? Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

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

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 minimum 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 of age: 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

GOOD NEIGHBOR PHARMACY Mineral Oil
 

Active Ingredient

Mineral Oil, USP 100%

Other Information
  • keep tightly closed
  • protect from direct light
Inactive Ingredient

Vitamin E as stabilizer

Principal Display Panel

SAFETY SEALED

Mineral Oil

Lubricant Laxative

Odorless-Tasteless

Crystal Clear

FL OZ (mL)

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

Distributed by AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

www.mygnp.com

Questions or comments? Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

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

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.682584 · Updated: 2026-03-14T23:08:21.075335