Swan 831.000/831AA

Manufacturer
Vi-Jon, LLC | Nice-Pak Products, LLC
Effective date
2026-09-22
Label type
HUMAN OTC DRUG LABEL
Version
20
Source
daily-update
Hydrated at
2026-09-25 02:02:00

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.

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: Vi-Jon

One Swan Drive

Smyrna, TN 37167

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0869-0831-43

SWAN ®

MINERAL OIL

U.S.P. LUBRICANT LAXATIVE

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

COMPARE TO ACTIVE INGREDIENT OF ROBERTS ®MINERAL OIL*

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130308694206105GTIN-13: 0308694206105
EAN-13: 0308694206105
GTIN-12: 308694206105
UPC-A: 308694206105
GTIN storage (14 digits): 00308694206105
mm02.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81

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
0869-08310869-0831-43

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
192026-03-12full-release2026-06-01 01:49:58

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii+route
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii+route
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii+route
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii+route
6 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
4cd5a2c4-2e8c-ae1c-e063-6394a90a90e53ffdbd3d-a711-4706-9596-c287e3957a932026-03-12Warnings, Adverse reactionsExact identifier
spl set id: 3ffdbd3d-a711-4706-9596-c287e3957a93

Reported adverse events (FAERS/openFDA)#

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