Safecor Health

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (1000 mg)

Inactive Ingredients

.alpha.-tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-10-01

Medication Information

Purpose

Lubricant Laxative

Dosage and Administration

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	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

Description

Mineral Oil USP

Use:

For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours

Section 50565-1

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.

Section 50566-9

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.

Section 50567-7

When using this product: Do not take with meals. Take only at bedtime.

Section 50568-5

Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.

Section 50569-3

Ask a doctor before use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.

Section 50570-1

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.

Section 51727-6

Inactive ingredients: Mixed tocopherols (added as a stabilizer)

NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204

Rev: 05/2019 PN5471

Section 53414-9

If breast feeding, ask a health care professional before use.

Section 60561-8

Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.

Active Ingredients

Mineral Oil USP

Principal Display Panel Lid Label

Delivers 30 mL

NDC 48433-202-30

Mineral Oil USP

Lubricant Laxative

DO NOT TAKE WITH MEALS

348433202302

Pkg By: Safecor Health, LLC

Columbus, OH 43204

Structured Label Content

Use:

For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours

Dosage and Administration (34068-7)

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	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

Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product: Do not take with meals. Take only at bedtime.

Section 50568-5 (50568-5)

Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.

Section 50569-3 (50569-3)

Ask a doctor before use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients: Mixed tocopherols (added as a stabilizer)

NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup

Mfd. in the U.S.A.

Distributed by: Safecor Health, LLC

4060 Business Park Drive, Columbus, OH 43204

Rev: 05/2019 PN5471

Section 53414-9 (53414-9)

If breast feeding, ask a health care professional before use.

Section 60561-8 (60561-8)

Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.

Purpose

Lubricant Laxative

Active Ingredients

Mineral Oil USP

Principal Display Panel Lid Label (Principal Display Panel - Lid Label)

Delivers 30 mL

NDC 48433-202-30

Mineral Oil USP

Lubricant Laxative

DO NOT TAKE WITH MEALS

348433202302

Pkg By: Safecor Health, LLC

Columbus, OH 43204

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use:": "For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours", "34068-7": "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 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", "50565-1": "Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. In case of eye contact, flush with water.", "50566-9": "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.", "50567-7": "When using this product: Do not take with meals. Take only at bedtime.", "50568-5": "Ask a Doctor or Pharmacist before use if you are: * presently taking a stool softener * taking any other drug. Take this product 2 or more hours before or after drugs. Laxatives may affect how other drugs work. Frequent or prolonged use may result in dependence.", "50569-3": "Ask a doctor before use if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks.", "50570-1": "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.", "51727-6": "Inactive ingredients: Mixed tocopherols (added as a stabilizer) NDC: 48433-202-30 Mineral Oil USP 30 mL Unit Dose Cup Mfd. in the U.S.A. Distributed by: Safecor Health, LLC 4060 Business Park Drive, Columbus, OH 43204 Rev: 05/2019 PN5471", "53414-9": "If breast feeding , ask a health care professional before use.", "60561-8": "Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.", "Purpose": "Lubricant Laxative", "Active Ingredients": "Mineral Oil USP", "Principal Display Panel - Lid Label": "Delivers 30 mL NDC 48433-202-30 Mineral Oil USP Lubricant Laxative DO NOT TAKE WITH MEALS 348433202302 Pkg By: Safecor Health, LLC Columbus, OH 43204"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information