Equaline 831.000/831aa

SPL v17

SPL

SPL Set ID cb7bc571-295f-47c2-ae93-18cba194752c

Routes

ORAL TOPICAL

Published

Effective Date 2025-03-27

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 2004-12-22

Description

Mineral oil 99.9%

Purpose

Lubricant laxative

Adverse Reactions

Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA Contact us at 1-877-932-7498, or www.supervalu-ourownbrands.com

Medication Information

Purpose

Lubricant laxative

Adverse Reactions

Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA

Description

Mineral oil 99.9%

Use

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

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 week
if you are bedridden or aged

Active Ingredient

Mineral oil 99.9%

If Breast Feeding

ask a health professional before use.

Other Information

keep tightly closed. Protect from sunlight.

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Questions Or Comments?

1-877-932-7948

Principal Display Panel

NDC 41163-831-43

EQUALINE ^®

mineral oil USP

lubricant laxative

for relief of occasional constipation

odorless
tasteless
colorless

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (473 mL)

When Using This Product

do not take with meals. Take only at bedtime.

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

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 week
if you are bedridden or aged

Active Ingredient (Active ingredient)

Mineral oil 99.9%

Adverse Reactions (Adverse reactions)

Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA

If Breast Feeding (If breast-feeding)

ask a health professional before use.

Other Information (Other information)

keep tightly closed. Protect from sunlight.

Inactive Ingredients (Inactive ingredients)

mixed tocopherols (added as a stabilizer)

Questions Or Comments? (Questions or comments?)

1-877-932-7948

Principal Display Panel (Principal display panel)

NDC 41163-831-43

EQUALINE ^®

mineral oil USP

lubricant laxative

for relief of occasional constipation

odorless
tasteless
colorless

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (473 mL)

When Using This Product (When using this product)

do not take with meals. Take only at bedtime.

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": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "999", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "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 week if you are bedridden or aged", "Active ingredient": "Mineral oil 99.9%", "Adverse reactions": "Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA Contact us at 1-877-932-7498, or www.supervalu-ourownbrands.com", "If breast-feeding": "ask a health professional before use.", "Other information": "keep tightly closed. Protect from sunlight.", "Inactive ingredients": "mixed tocopherols (added as a stabilizer)", "Questions or comments?": "1-877-932-7948", "Principal display panel": "NDC 41163-831-43 EQUALINE ® mineral oil USP lubricant laxative for relief of occasional constipation odorless tasteless colorless SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION 16 FL OZ (473 mL)", "When using this product": "do not take with meals. Take only at bedtime.", "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

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Source: dailymed · Ingested: 2026-02-15T12:05:48.415553 · Updated: 2026-03-14T23:13:47.581346