Package Label

Package Label
SPL v7
SPL
SPL Set ID d1d81cab-f879-4c01-b306-eff76320e0ef
Routes
ORAL TOPICAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Mineral Oil 100%


Medication Information

Indications and Usage

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours

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 under 12 years, consult a doctor 

Description

Mineral Oil 100%

Section 42229-5

keep tightly closed protect from direct light

Section 50565-1

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

Section 50566-9

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

Section 50567-7

do not take with meals take only at bedtime

Section 50569-3

abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks

Section 50570-1

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week

Section 51727-6

Vitamin E as stabilizer

Section 51945-4

MINERAL OIL LUBRICANT LAXATIVE odorless • tasteless colorless FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Section 53414-9

ask a health professional before use

Section 55105-1

Lubricant laxative

Section 55106-9

Mineral Oil 100%


Structured Label Content

Indications and Usage (34067-9)

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours

Dosage and Administration (34068-7)

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 under 12 years, consult a doctor 

Section 42229-5 (42229-5)

keep tightly closed protect from direct light

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

do not take with meals take only at bedtime

Section 50569-3 (50569-3)

abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks

Section 50570-1 (50570-1)

in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing if you are presently taking a stool softener laxative for longer than 1 week

Section 51727-6 (51727-6)

Vitamin E as stabilizer

Section 51945-4 (51945-4)

MINERAL OIL LUBRICANT LAXATIVE odorless • tasteless colorless FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Section 53414-9 (53414-9)

ask a health professional before use

Section 55105-1 (55105-1)

Lubricant laxative

Section 55106-9 (55106-9)

Mineral Oil 100%


Raw Label Data

All Sections (JSON)