Mineral Oil Lubricant Laxative 99.9%

Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-08 02:02:37

Label at a glance#

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

Label contents#

Full prescribing information#

Disclaimer

SPL UNCLASSIFIED SECTION

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

Active ingredients

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 productes bowel movement in 6 to 8 hours.

Warnings

WARNINGS SECTION

Do not use

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

OTC - STOP USE SECTION

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of 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. (1-800-222-1222)

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 12 years of age - 1 to 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)

Adverse reaction

ADVERSE REACTIONS SECTION

Distributed by:

Atlantic Biologicals Corp.

Miami, FL 33179

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 17856-1831-05

MINERAL OIL, U.S.P.

LUBRICANT LAXATIVE

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

*COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

55

NDC 17856-1831-08

MINERAL OIL, U.S.P.

LUBRICANT LAXATIVE

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

*COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

88

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00317856183154(17)270303(10)027422(21)0274221000GTIN-14: 00317856183154
GTIN-12: 317856183154
UPC-A: 317856183154
EAN-13: 0317856183154
GTIN storage (14 digits): 00317856183154
17856-1831-05 Rev. 1 Case Label.jpg
BarcodeData Matrix(01)00317856183185(17)270303(10)027421(21)0274211000GTIN-14: 00317856183185
GTIN-12: 317856183185
UPC-A: 317856183185
EAN-13: 0317856183185
GTIN storage (14 digits): 00317856183185
17856-1831-08 Rev. 1 Case Label.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0869-0831-43ML - Milliliter0869-08310a309983-7e68-486f-a582-1ca52fe8d1f212013-06-04

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
17856-183117856-1831-5, 17856-1831-8
0869-0831

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
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
ndc (package): 17856-1831-5
ndc (package): 17856-1831-8
ndc (product): 17856-1831
ndc11 (package): 17856183108
ndc11 (package): 17856183105
spl id: 5a821986-f187-540a-e063-6394a90ac67e
spl set id: 5a82197b-281d-76c0-e063-6294a90a5746

Reported adverse events (FAERS/openFDA)#

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