Swan 831.000/831AA

Manufacturer
Nice-Pak Products, LLC
Effective date
2026-09-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-25 02:01:19

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

Storage and handling

keep tightly closed.  Protect from sunlight

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.

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 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 wrok.

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 (5 to 15 mL) in 24 hours

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

Other information

STORAGE AND HANDLING 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: Consumer Product Partners, LLC

St. Louis, MO 63114 • 1-888-593-0593

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SWAN ®

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 descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0003515FCmm01.jpg

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
11344-83111344-831-43

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
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-03-13full-release2026-06-01 01:49:57

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
4ceab98a-1e54-2ceb-e063-6294a90a52ac3780aee2-7018-4c65-8991-be4e98b7339e2026-03-13Warnings, Adverse reactionsExact identifier
spl set id: 3780aee2-7018-4c65-8991-be4e98b7339e

Reported adverse events (FAERS/openFDA)#

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