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Drug Facts

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-10-10 01:03:02

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: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL children under 6 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 wormen, 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 you have

OTC - STOP USE SECTION

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. As with any drug, if you are nursing a baby, seek the advice of a health professional before using this product

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: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mL
  • children 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL
  • children under 6 years, consult a doctor 

Other Information

SPL UNCLASSIFIED SECTION

  • keep tightly closed
  • protect from direct light

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Vitamin E as stabilizer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Oil

LUBRICANT LAXATIVE

  • For Relief of Occasional Constipation
  • Odorless
  • Tasteless
  • Colorless

FL OZ (mL)

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

Questions or comments? Call toll free 1-888-423-0139

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH Mineral OilTOPCARE HEALTH Mineral Oil 

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800247123GTIN-13: 0036800247123
EAN-13: 0036800247123
GTIN-12: 036800247123
UPC-A: 036800247123
GTIN storage (14 digits): 00036800247123		mineral-oil-liquid-delisted-1.jpg

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
36800-33436800-334-16

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-04-24full-release2026-06-01 00:59:39

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 OILTOP CARE (Topco Associates LLC)0dd5380e-9671-4a2b-a2ce-6477503d06d22025-04-24WarningsExact identifier
ndc (package): 36800-334-16
ndc (product): 36800-334
ndc11 (package): 36800033416
spl set id: 0dd5380e-9671-4a2b-a2ce-6477503d06d2

Reported adverse events (FAERS/openFDA)#

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