Leader Mineral Oil

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (1000 mg)

Inactive Ingredients

.alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2018-12-18 Until 2027-02-28

Medication Information

Warnings and Precautions

Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

Indications and Usage

For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

Dosage and Administration

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

Children under 6 yrs of age: Consult a doctor before use

Description

Mineral Oil

Section 50565-1

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

Section 50566-9

and consult a doctor if there is a fialure to have a bowel movement after use.

Section 50569-3

Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Section 51727-6

dl-alpha-tocopherol as a preservative

Section 51945-4

Section 55105-1

Lubricant Laxative

Section 55106-9

Mineral Oil

Section 60561-8

Keep tightly closed and protected from direct light

Structured Label Content

Indications and Usage (34067-9)

For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.

Dosage and Administration (34068-7)

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.

Children under 6 yrs of age: Consult a doctor before use

Warnings and Precautions (34071-1)

Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative

Section 50565-1 (50565-1)

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

Section 50566-9 (50566-9)

and consult a doctor if there is a fialure to have a bowel movement after use.

Section 50569-3 (50569-3)

Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.

Section 51727-6 (51727-6)

dl-alpha-tocopherol as a preservative

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Lubricant Laxative

Section 55106-9 (55106-9)

Mineral Oil

Section 60561-8 (60561-8)

Keep tightly closed and protected from direct light

Advanced Ingredient Data

[{"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.", "34068-7": "Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime. Children under 6 yrs of age: Consult a doctor before use", "34071-1": "Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative", "50565-1": "In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.", "50566-9": "and consult a doctor if there is a fialure to have a bowel movement after use.", "50569-3": "Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.", "51727-6": "dl-alpha-tocopherol as a preservative", "55105-1": "Lubricant Laxative", "55106-9": "Mineral Oil", "60561-8": "Keep tightly closed and protected from direct light"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information