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

Label at a glance#

ProductMineral oil

Active ingredientMINERAL OIL

Label structure16 sections

Dosage and administration

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

Storage and handling

keep tightly closed. Protect from sunlight.

Label contents#

Full prescribing information#

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

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

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	L0021812FA		mm01.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Mineral oil
TOCOPHEROL

NDC Codes#

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

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOCOPHEROL	R0ZB2556P8	IACT
MINERAL OIL	T5L8T28FGP	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2026-02-03	full-release	2026-06-01 01:36:25

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral oil	MINERAL OIL	CVS Pharmacy, Inc.	1183bcbc-51ec-e53a-e063-6394a90af0f2	2026-06-26	Warnings, Adverse reactions	Exact identifier ndc (package): 51316-831-45 ndc (package): 51316-831-43 ndc (product): 51316-831 ndc11 (package): 51316083145 ndc11 (package): 51316083143 spl id: 5528eed0-1a93-0fd9-e063-6394a90a6e2e spl set id: 1183bcbc-51ec-e53a-e063-6394a90af0f2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.