Mineral Oil by Kesin Pharma Corporation MINERAL OIL solution

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Mineral Oil (100%)

Lubricant Laxative

There are no other inactive ingredients.

Purpose

Lubricant Laxative

Uses

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

Warnings

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

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

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.

When using

When using this product

• do not take with meals
• take only at bedtime

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.

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.

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

Questions or comments ?

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Packaged by:
Kesin Pharma
Oldsmar, FL 34677

Rev. 03/2025

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-042(NDC:48433-202)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	1000 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-042-50	50 in 1 CARTON	03/01/2025
1	NDC: 81033-042-30	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	03/01/2025

Labeler - Kesin Pharma Corporation (117447816)