Top Care 831.000/831aa

SPL v12

SPL

SPL Set ID e9b1fd61-c229-4529-82c2-d6ac5b076082

Routes

ORAL TOPICAL

Published

Effective Date 2025-09-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (999 mg)

Inactive Ingredients

Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-12-22

Description

QUALITY GUARANTEED

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

QUALITY GUARANTEED

Use

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

Claim

QUALITY GUARANTEED

Warnings

for this product

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 - 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

Do Not Use

if you have difficulty swallowing
in children under 6 years of age
if you are pregnant
for a period longer than week
if you are bedridden or aged

Questions?

Call 1-888-423-0139

Active Ingredient

Mineral oil 99.9%

Other Information

keep tightly closed. Protect from sunlight.

If Breast Feeding,

ask a health professional before use

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

When Using This Product

do not take with meals. Take only at bedtime.

Principal Display Panel

NDC 36800-931-43

TopCare ^®

health

Mineral Oil

U.S.P.

LUBRICANT LAXATIVE

For Relief of Occasional Constipation
Odorless
Tasteless
Colorless

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0521 QUESTIONS? 1-888-423-0139

[email protected] www.topcareband.com

PRODUCT OF USA WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Scan here for more information or call 1-888-423-0139

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 a serious condition.

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 produces bowel movement in 6 to 8 hours.

Claim

QUALITY GUARANTEED

Purpose

Lubricant laxative

Warnings

for this product

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 - 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

Do Not Use (Do not use)

if you have difficulty swallowing
in children under 6 years of age
if you are pregnant
for a period longer than week
if you are bedridden or aged

Questions?

Call 1-888-423-0139

Active Ingredient (Active ingredient)

Mineral oil 99.9%

Other Information (Other information)

keep tightly closed. Protect from sunlight.

If Breast Feeding, (If breast-feeding,)

ask a health professional before use

Inactive Ingredients (Inactive ingredients)

mixed tocopherols (added as a stabilizer)

When Using This Product (When using this product)

do not take with meals. Take only at bedtime.

Principal Display Panel (principal display panel)

NDC 36800-931-43

TopCare ^®

health

Mineral Oil

U.S.P.

LUBRICANT LAXATIVE

For Relief of Occasional Constipation
Odorless
Tasteless
Colorless

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcareband.com

PRODUCT OF USA WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

Scan here for more information or call 1-888-423-0139

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 a serious condition.

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": "999", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 6 to 8 hours.", "Claim": "QUALITY GUARANTEED", "Purpose": "Lubricant laxative", "Warnings": "for this product", "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 - 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", "Do not use": "if you have difficulty swallowing in children under 6 years of age if you are pregnant for a period longer than week if you are bedridden or aged", "Questions?": "Call 1-888-423-0139", "Active ingredient": "Mineral oil 99.9%", "Other information": "keep tightly closed. Protect from sunlight.", "If breast-feeding,": "ask a health professional before use", "Inactive ingredients": "mixed tocopherols (added as a stabilizer)", "When using this product": "do not take with meals. Take only at bedtime.", "principal display panel": "NDC 36800-931-43 TopCare ® health Mineral Oil U.S.P. LUBRICANT LAXATIVE For Relief of Occasional Constipation Odorless Tasteless Colorless DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0521 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcareband.com PRODUCT OF USA WITH US AND FOREIGN COMPONENTS SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION Scan here for more information or call 1-888-423-0139 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 a serious condition.", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:06.669008 · Updated: 2026-03-14T23:13:44.961646