CVS 831.000/831AA

Manufacturer
CVS Pharmacy, Inc. | Nice-Pak Products, LLC
Effective date
2026-06-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:36:30

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Uses

Use

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

Warnings

Warnings

for this product

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

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.

Directions And Dosage

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

Other Label Information

Other information

keep tightly closed. Protect from sunlight.

Inactive ingredients

mixed tocopherols (added as a stabilizer)

PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION NDC 51316-831-43 CVS™ Mineral Oil USP LUBRICANT LAXATIVE Odorless & Tasteless 6-8 HRS DYE FREE 16 FL OZ (1 PT) 473 mL

Label Images#

mm01
mm01
mm02
mm02

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-83151316-831-43, 51316-831-45

Ingredients#

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
MINERAL OILT5L8T28FGPACTIB

Complete SPL Sections#

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 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 work.

When using this product

OTC - WHEN USING SECTION

do not take with meals. Take only at bedtime.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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: CVS Pharmacy, Inc. One CVS Drive, Woodsocket, RI 02895 ©2024 V-16453

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION NDC 51316-831-43 CVS™ Mineral Oil USP LUBRICANT LAXATIVE Odorless & Tasteless 6-8 HRS DYE FREE 16 FL OZ (1 PT) 473 mL

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-02-03full-release2026-06-01 01:36:25