Mineral Oil by Safecor Health, LLC MINERAL OIL solution

Mineral Oil by

Drug Labeling and Warnings

Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Mineral Oil USP

Purpose

Lubricant Laxative

Use:

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

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.

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

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

INGREDIENTS AND APPEARANCE

MINERAL OIL 
mineral oil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-202-30	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product	10/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/01/2014

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Sonneborn, LLC		613030811	MANUFACTURE(48433-202)