FDA Label for Mineral Oil

View Indications, Usage & Precautions

ACTIVE INGREDIENTS
PURPOSE
USE:
OTC - DO NOT USE
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
OTHER SAFETY INFORMATION
INACTIVE INGREDIENT
PRINCIPAL DISPLAY PANEL - LID LABEL

Mineral Oil Product Label

The following document was submitted to the FDA by the labeler of this product Safecor Health, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients

Mineral Oil USP

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