Mineral oil

Manufacturer
Best Choice (Valu Merchandisers Company)
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:54:23

Label at a glance#

ProductMineral oil
Active ingredientMINERAL OIL
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours

Dosage and administration

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 tablespoon (45 mL) in 24 hours children under 12 years, consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

lubricant laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 8 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years of age, pregnant women, bedridden patients or aged, or if you have difficulty swallowing
  • if you are presently taking a stool softener laxative
  • for longer than 1 week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • do not take with meals
  • take only at bedtime

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 tablespoon (45 mL) in 24 hours
  • children under 12 years, consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • keep tightly closes
  • protect from direct light

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vitamin E as stabilizer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Oil

Lubricant Laxative U.S.P.

•Odorless • Tasteless • Colorless

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

Questions or comments?

Call 1-877-753-3935

Monday-Friday 9AM-5PM EST

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice Mineral Oil
Best Choice Mineral Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-334-16Mineral oil473 mL in 1 BOTTLEOIL4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-334MINERAL OIL OIL [BEST CHOICE (VALU MERCHANDISERS COMPANY)]5Current NDC, Legacy NDC, 1 package rows20250206_3ec8a716-60e0-4dfb-adae-ddc53c613935.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63941-33463941-334-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
ndc (package): 63941-334-16
ndc (product): 63941-334
ndc11 (package): 63941033416
spl id: 0ea9a1d4-eb05-4bd8-a200-eb3ec76cb82c
spl set id: 3ec8a716-60e0-4dfb-adae-ddc53c613935

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.