Mineral Oil

Manufacturer
Foodhold U.S.A. | Vi-Jon
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:30:49

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL
Label structure16 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 - 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
  • 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 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 and ask a doctor

OTC - STOP USE SECTION

if 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 - 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)

Questions

OTC - QUESTIONS SECTION

Questions? Call 1-877-846-9949

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

2018 Ahold Delhaize Licensing Sari Quality guaranteed or your money back.

831.000/831AA

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE

MINERAL OIL

USP

Lubricant Laxative

For relief of occaskonal contipation

ODORLESS - TASTELESS - COLORLESS

MADE IN THE USE WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

OUR PHARMACISTS RECOMMEND

16 FL OZ (1 PT) 473 mL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-877-432023-10-25C16284748780-1d6a99b39-5822-a426-e053-dadaa90af4c2Mineral Oil 831
41520-877-432022-01-28C16284748780-1d6a99b39-5822-a426-e053-dadaa90af4c2Mineral Oil 831

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
41520-87741520-877-43

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
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

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
25d79e80-6f22-4a65-9758-829b51e99feb1848ae5e-527f-44ca-8191-04403bc2d0c22023-10-24WarningsExact identifier
spl set id: 1848ae5e-527f-44ca-8191-04403bc2d0c2

Reported adverse events (FAERS/openFDA)#

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