Mineral Oil
Mineral Oil USP 831.000/831AA
960502ae-2468-406e-8799-cacb01f2727e
HUMAN OTC DRUG LABEL
May 23, 2025
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mineral Oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
NDC 17856-1110-01
INDICATIONS & USAGE SECTION
Use
for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.
WARNINGS SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- abdominal pain, nausea, or vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
SPL UNCLASSIFIED SECTION
(c) 2023 McKesson Corporaation
You may report serious side effects to 833-358-6431
Monday to Friday 9:00am to 7:00pm EST
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Mineral oil 99.9%
OTC - PURPOSE SECTION
Purpose
Lubricant laxative
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- presently taking a stool softener laxative
- taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
OTC - WHEN USING SECTION
When using this product
do not take with meals. Take only at bedtime.
OTC - STOP USE SECTION
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 SECTION
If breast-feeding,
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours
children under 6 years of age - do not use, consult a doctor
STORAGE AND HANDLING SECTION
Other Information
keep tightly closed. Protect from sunlight.
INACTIVE INGREDIENT SECTION
Inactive ingredients
mixed tocopherols (added as a stabilizer)