Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 68e88119-1468-4ab7-a5fa-242d960d25df
Route
ORAL
Published
Effective Date 2025-02-21
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 2014-08-31
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 minimum single dose of 15 mL to a maximum daily dose of 45 mL
  • children 6 years 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 12 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 longer than 1 week
Package Label
READYinCASE Mineral Oil
Active Ingredient

Mineral oil 100%

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

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

lubricant laxative

  • odorless
  • tasteless
  • colorless

FL OZ (mL)

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

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

Manufactured by:

PL Developments

513 Old Griffin Road

Piedmont, SC 29673

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.

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 minimum single dose of 15 mL to a maximum daily dose of 45 mL
  • children 6 years 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 12 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 longer than 1 week
Package Label
READYinCASE Mineral Oil
Active Ingredient (Active ingredient)

Mineral oil 100%

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

Vitamin E as stabilizer

Principal Display Panel

Mineral Oil

lubricant laxative

  • odorless
  • tasteless
  • colorless

FL OZ (mL)

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

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

Manufactured by:

PL Developments

513 Old Griffin Road

Piedmont, SC 29673

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.

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:36.235310 · Updated: 2026-03-14T23:07:39.601528