Active Ingredients
Mineral Oil USP
Mineral Oil Solution
FDA Label NDC 48433-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safecor Health, Llc for the product Mineral Oil (NDC 48433-202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use:, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant Laxative
Use:
For relief of occasional constipation (irregularity). Generally produces bowel movements in 6 to 8 hours
Otc - 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.
Otc - Ask Doctor
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.
Otc - Ask Doctor/Pharmacist
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.
Otc - When Using
When using this product: Do not take with meals. Take only at bedtime.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If breast feeding, ask a health care professional before use.
Otc - 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.
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 Safety Information
Other information: Keep tightly closed. Protect from sunlight. For more info call 800-447-1006.
Inactive Ingredient
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
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)
* Please review the disclaimer below.
