FDA.reportPublic FDA data

Humco Mineral Oil Heavy

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:38

Label at a glance#

ProductHumco Mineral Oil Heavy
Active ingredientMINERAL OIL
Label structure12 sections

Dosage and administration

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime. Children under 6 yrs. of age: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil Heavy

Purpose

OTC - PURPOSE SECTION

Laxative

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.

Warnings

WARNINGS SECTION

Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.

Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you are currently taking a stool softener laxative.

If pregnant or brest feeding ask a health professional before use.

When using this Product discotinue use

OTC - STOP USE SECTION

and consult a doctor if there is a failure to have a bowel movement after use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.

Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.

Children under 6 yrs. of age: Consult a doctor before use.

Inactive ingredient

INACTIVE INGREDIENT SECTION

dl-alpha-tocopherol as a preservative.

Other information

OTHER SAFETY INFORMATION

Keep tightly closed and protect from direct light.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

capture(2)capture(2)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311714heavy mineral oil 100 % Oral SolutionPSN5
311714heavy mineral oil 1000 MG/ML Oral SolutionSCD5
311714heavy mineral oil 100 % Oral SolutionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-1685-28Humco Mineral Oil Heavy3800 mL in 1 BOTTLE, PLASTICLIQUID38005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-1685HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.]5Current NDC, Legacy NDC, 1 package rows20231216_9f943fdf-5058-4e18-ba96-6be112bf72ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-1685-28ML - Milliliter0395-1685cfeb10af-aa83-4b74-ace2-c2eecabc965f12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-16850395-1685-28

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
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
MINERAL OILT5L8T28FGPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8AEROSOL, FOAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates

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
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
ndc (package): 0395-1685-28
ndc (product): 0395-1685
ndc11 (package): 00395168528
spl id: 0c93390b-bca4-9c43-e063-6294a90aeffb
spl set id: 9f943fdf-5058-4e18-ba96-6be112bf72ca

Reported adverse events (FAERS/openFDA)#

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