Mineral Oil MINERAL OIL SAFECOR HEALTH, LLC FDA Approved Use: For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours
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Substance Mineral Oil
Route
ORAL
Applications
M334
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Mineral Oil USP
Inactive Ingredients
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
Quantities
30 ml
Treats Conditions
Use For Relief Of Occasional Constipation Irregularity Generally Produces Bowel Movements In 6 To 8 Hours

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
T5L8T28FGP
Packaging

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 Principal Display Panel - Lid Label

Package Descriptions
  • 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 Principal Display Panel - Lid Label

Overview

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

Indications & Usage

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

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

Warnings & Precautions
WARNINGS: 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 if you have *abdominal pain, nausea, or vomiting *noticed a sudden change in bowel habits that persist over a period of 2 weeks. 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. 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 breast feeding , ask a health care professional before use. 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.
Purpose

Purpose Lubricant Laxative

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.

When Using

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

Stop Use & 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.

Keep Out of Reach of Children

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.


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