Mineral Oil

Manufacturer: Shopko Stores Operating Co., LLC | Consumer Product Partners, LLC
Effective date: 2024-09-26
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: legacy-cache
Hydrated at: 2026-08-01 20:54:14

Label at a glance#

ProductMineral Oil

Active ingredientMINERAL OIL

Label structure15 sections

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 ad over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours children under 6 years of age - do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 99.9%

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Use

INDICATIONS & USAGE SECTION

for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.

Do not use

WARNINGS SECTION

if you have difficulty swallowing
if you are pregnant
if you are bedridden or aged
in children under 6 years of age
for a period 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a stool softener laxative
taking any other drug. Take this product 2 or more hours before or after othr drugs. Laxatives may affect how other drugs work

When using this product

OTC - WHEN USING SECTION

do not take with meals. Take only at bedtime.

Stop use ad ask a doctor

OTC - STOP USE SECTION

if you have rectal bleeding or failure to have a bowel movement after use. The coudlbe signs of a serious condition.

If 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 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 ad over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Other information

SPL UNCLASSIFIED SECTION

keep tightly closed. Protect from sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mixed tocopherols (added as a stabilizer)

SPL UNCLASSIFIED SECTION

Made in the USA with US and foreign components

Manufactured by Vi-Jon, Inc

One Swan Drive, Smyrna, TN 37167

for ShopKo Stores Operating Co. LLC

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO

Mineral

Oil

U.S.P.

Lubricant Laxative

For Relief of Occasional Constipation

Odorless
Tasteless
Colorless

Sealed with printed foil under cap for your protection

16 FL OZ (1 PT) 473 mL

image description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1

Products#

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

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

Mineral Oil
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37012-831	37012-831-43

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
Name	UNII	Kind
TOCOPHEROL	R0ZB2556P8	IACT
MINERAL OIL	T5L8T28FGP	ACTIB

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 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Match
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE / ORAL	NA	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA	Exact identifier — unii candidate 5 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CAPSULE, COATED / ORAL	0.25 mg	Exact identifier — unii candidate 5 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
253f5c7d-0186-35e5-e063-6294a90a4e4d			e71e8fae-197b-4eb8-be86-c752e9af3f33	2024-10-24	Warnings	Exact identifier spl set id: e71e8fae-197b-4eb8-be86-c752e9af3f33

Reported adverse events (FAERS/openFDA)#

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