Swan 831.000/831aa

SPL v18

SPL

SPL Set ID 3ffdbd3d-a711-4706-9596-c287e3957a93

Route

ORAL

Published

Effective Date 2025-03-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (1 mg)

Inactive Ingredients

Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1989-07-15

Description

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

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

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

Use

for relief of occasional constipation (irregularity). Generally productes bowel movement in 6 to 8 hours.

Warnings

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

Directions

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

Disclaimer

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

Adverse Reaction

Distributed by: Vi-Jon

One Swan Drive

Smyrna, TN 37167

If Breast Feeding

ask a health professional before use.

Other Information

keep tightly closed. Protect from sunlight

Active Ingredients

Mineral oil 99.9%

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

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

Stop Use and Ask A Doctor

if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of serious condition

When Using This Product

do not take with meals. Take only at bedtime.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

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

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.

Structured Label Content

Use

for relief of occasional constipation (irregularity). Generally productes bowel movement in 6 to 8 hours.

Purpose

Lubricant laxative

Warnings

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

Directions

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

Disclaimer

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

Adverse Reaction (Adverse reaction)

Distributed by: Vi-Jon

One Swan Drive

Smyrna, TN 37167

If Breast Feeding (If breast-feeding)

ask a health professional before use.

Other Information (Other information)

keep tightly closed. Protect from sunlight

Active Ingredients (Active ingredients)

Mineral oil 99.9%

Inactive Ingredients (inactive ingredients )

mixed tocopherols (added as a stabilizer)

Principal Display Panel (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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of serious condition

When Using This Product (When using this product )

do not take with meals. Take only at bedtime.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have )

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 (Ask a doctor or pharmacist before use if you are )

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.

Advanced Ingredient Data

[{"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional constipation (irregularity). Generally productes bowel movement in 6 to 8 hours.", "Purpose": "Lubricant laxative", "Warnings": "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", "Directions": "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", "Disclaimer": "*This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts ® Mineral Oil.", "Adverse reaction": "Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167", "If breast-feeding": "ask a health professional before use.", "Other information": "keep tightly closed. Protect from sunlight", "Active ingredients": "Mineral oil 99.9%", "inactive ingredients ": "mixed tocopherols (added as a stabilizer)", "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", "Stop use and ask a doctor": "if you have rectal bleeding or failure to have a bowel movement after use. These could be signs of serious condition", "When using this product ": "do not take with meals. Take only at bedtime.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have ": "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 ": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.021933 · Updated: 2026-03-14T23:08:04.646392