Mineral Oil

Manufacturer: Cardinal Health | Vi-Jon, LLC
Effective date: 2021-03-15
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 22:48:55

Label at a glance#

ProductMineral Oil

Active ingredientMINERAL OIL

Label structure8 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 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 (15mL) in 24 hours children under 6 years of age - do not use, consult a doctor

Contacts and useful links#

PhoneLabel contact1-800-260-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 99.99%

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

Warnings

WARNINGS SECTION

for this product

Do not use

OTC - DO NOT USE SECTION

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

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 other 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 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 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 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 (15mL) in 24 hours
children under 6 years of age - do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

keep tightly closed. Protect from sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

mixed tocopherols (added as a stabilizer)

adverse reaction

ADVERSE REACTIONS SECTION

*This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts Mineral Oil

Distributed by Cardinal Health, Dublin, Ohio 43017
www.myleader.com 1-800-260-6313

831.000/831AA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-831-43

LEADER

COMPARE TO ROBERTS ACTIVE INGREDIENT

MINERAL

OIL

U.S.P.

Lubriant Lazative

For Relief of Occasional Constipation

Odorless - Tasteless - Colorless

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

SATISFACTION GUARANTEED

16 FL OZ (1 PT) 473 mL

image description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-831-43	ML - Milliliter	37205-831	dec812a0-2512-48a5-ad58-6d037975fe7d	1	2012-07-24

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
37205-831	37205-831-43

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
MINERAL OIL	T5L8T28FGP	ACTIB
TOCOPHEROL	R0ZB2556P8	IACT

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	INJECTION, EMULSION / INTRAVENOUS	0.02 %w/v	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
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA	Exact identifier — unii candidate 5 equally ranked IID candidates
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

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
9abd2aef-3cbd-4210-a28c-420f160ff339			32b7bc0d-d909-41df-a465-bd99261948e5	2021-06-29	Warnings, Adverse reactions	Exact identifier spl set id: 32b7bc0d-d909-41df-a465-bd99261948e5

Reported adverse events (FAERS/openFDA)#

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