Care One 831.000/831aa

SPL v7

SPL

SPL Set ID b0abcdf9-c226-424f-8970-c2135708c6c8

Routes

ORAL TOPICAL

Published

Effective Date 2025-06-27

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 2018-07-09

Description

Mineral oil 99.9%

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Mineral oil 99.9%

Use

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

Questions

Call 1-877-846-9949

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 under 12 years of age - 1 to 3 teaspoons (5 to 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 1 week
if you are bedridden or aged

Adverse Reaction

DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

Quality guaranteed or your money back.

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

CAREONE ^®

MINERAL OIL

USP

Lubricant Laxative

For relief of occasional constipation

ODORLESS - TASTELESS - COLORLESS

MADE IN THE USE WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

OUR PHARMACISTS RECOMMEND

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.

Purpose

Lubricant laxative

Questions

Call 1-877-846-9949

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 under 12 years of age - 1 to 3 teaspoons (5 to 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 1 week
if you are bedridden or aged

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785

For product questions or concerns, contact us at 1-877-846-9949

Quality guaranteed or your money back.

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)

CAREONE ^®

MINERAL OIL

USP

Lubricant Laxative

For relief of occasional constipation

ODORLESS - TASTELESS - COLORLESS

MADE IN THE USE WITH US AND FOREIGN COMPONENTS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

OUR PHARMACISTS RECOMMEND

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.", "Purpose": "Lubricant laxative", "Questions": "Call 1-877-846-9949", "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 under 12 years of age - 1 to 3 teaspoons (5 to 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 1 week if you are bedridden or aged", "ADVERSE REACTION": "DISTRIBUTED BY: FOODHOLD U.S.A., LLC, LANDOVER, MD 20785 For product questions or concerns, contact us at 1-877-846-9949 ©2018 Ahold Delhaize Licensing Sari Quality guaranteed or your money back.", "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": "CAREONE ® MINERAL OIL USP Lubricant Laxative For relief of occasional constipation ODORLESS - TASTELESS - COLORLESS MADE IN THE USE WITH US AND FOREIGN COMPONENTS SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION OUR PHARMACISTS RECOMMEND 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: 2026-02-15T12:08:34.568023 · Updated: 2026-03-14T23:12:50.471535