Mineral Oil, Usp 30 Ml

Mineral Oil, Usp 30 Ml
SPL v1
SPL
SPL Set ID 30a11cc9-e407-23b7-e063-6294a90a7d6e
Route
ORAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (1000 mg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01
Description

Active Ingredient Mineral Oil (100%) Lubricant Laxative

Purpose

Lubricant Laxative

Medication Information

Purpose

Lubricant Laxative

Description

Active Ingredient Mineral Oil (100%) Lubricant Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours
Section 42229-5

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 03/2025

Section 51727-6

There are no other inactive ingredients.

Section 51945-4

NDC 81033-042-50

Mineral Oil, USP 30 mL

Delivers 30 mL

FOR INSTITUTIONAL ONLY

50 x 30 mL Unit Dose Cups

Store at 68ºF to 77ºF (20ºC to 25ºC)

Directions
  • do not take with meals
  • take only at bedtime
  • may be taken as a single dose or as directed by a doctor

Age Dose
adults and children 12 years of age and over 1 to 3 Tablespoons (15 mL to 45 mL)

maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL)

maximum 3 teaspoons (15 mL) in 24 hours
children under 6 years do not use. consult a doctor.

Do Not Use

Do not use

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged
Drug Facts

Active Ingredient

Mineral Oil (100%)

Lubricant Laxative

When Using

When using this product

  • do not take with meals
  • take only at bedtime
Other Information
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from direct light
  • NDC 81033-042-30: 30 mL unit dose cup
  • NDC 81033-042-50: Carton containing 50 - 30 mL unit dose cups
Ask A Doctor 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
Questions Or Comments ?

Call 1-833-537-4679

Stop Use and Ask A Doctor

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 Breastfeeding

If pregnant or breastfeeding, 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 right away.

Ask A Doctor Or Pharmacist Before Use

Ask a doctor or pharmacist before use if you are

  • presently taking a stool softener laxative
  • taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours
Section 42229-5 (42229-5)

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 03/2025

Section 51727-6 (51727-6)

There are no other inactive ingredients.

Section 51945-4 (51945-4)

NDC 81033-042-50

Mineral Oil, USP 30 mL

Delivers 30 mL

FOR INSTITUTIONAL ONLY

50 x 30 mL Unit Dose Cups

Store at 68ºF to 77ºF (20ºC to 25ºC)

Purpose

Lubricant Laxative

Directions
  • do not take with meals
  • take only at bedtime
  • may be taken as a single dose or as directed by a doctor

Age Dose
adults and children 12 years of age and over 1 to 3 Tablespoons (15 mL to 45 mL)

maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age 1 to 3 teaspoons (5 mL to 15 mL)

maximum 3 teaspoons (15 mL) in 24 hours
children under 6 years do not use. consult a doctor.

Do Not Use (Do not use)

Do not use

  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged
Drug Facts

Active Ingredient

Mineral Oil (100%)

Lubricant Laxative

When Using (When using)

When using this product

  • do not take with meals
  • take only at bedtime
Other Information (Other information)
  • store at 20°C to 25°C (68°F to 77°F)
  • protect from direct light
  • NDC 81033-042-30: 30 mL unit dose cup
  • NDC 81033-042-50: Carton containing 50 - 30 mL unit dose cups
Ask A Doctor Before Use (Ask a doctor 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
Questions Or Comments ? (Questions or comments ?)

Call 1-833-537-4679

Stop Use and Ask A Doctor (Stop use and ask a doctor)

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 Breastfeeding (If pregnant or breastfeeding)

If pregnant or breastfeeding, ask a health professional before use.

Keep Out of Reach of Children. (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 right away.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

Ask a doctor or pharmacist before use if you are

  • presently taking a stool softener laxative
  • taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.666240 · Updated: 2026-03-14T23:08:01.024401