Leader Ready to Use Mineral Oil

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 118 mL delivered dose)

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional constipation
• for relief of fecal impaction
• for removal of residue after barium administration

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

• if you have abdominal pain, nausea, or vomiting
• if you have a sudden change in bowel habits that persists over a period of 2 weeks
• if you have already used a laxative for more than 1 week
• if constipation continues after one week of use, contact your doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

• you have rectal bleeding or no bowel movement within 15 minutes of using this product
• you need to use a laxative for more than one week

These symptoms may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Single daily dose (per 24 hours).

adults & children 12 years and over	1 bottle once daily
children 2 to under 12 years	1/2 bottle once daily discard unused portion
children under 2 years	DO NOT USE

Other information

STORAGE AND HANDLING SECTION

• store at 15°-30°C (59°-86°F)
• this product generally produces a bowel movement in 2 to 15 minutes

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-866-323-0107

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER_™

NDC 70000-0109-1

Ready-To-Use
Enema
Mineral Oil
Lubricant Laxative

Sodium Free

For Relief Of:

Occasional
Constipation

Comfortable,
Lubricated Tip

Works in
Minutes

Not Made
With Natural
Rubber
Latex

COMPARE TO
FLEET^® MINERAL
OIL ENEMA
active ingredient*

1 BOTTLE

100% Money
Back Guarantee

4 .5 FL OZ (133 mL)

DailyMed RxNorm Mappings#

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Products#

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

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

• Leader Ready to Use Mineral Oil Laxative
• mineral oil

NDC Codes#

Ingredients#

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

Source Document#

Source XML

openFDA label cross-check#

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Reported adverse events (FAERS/openFDA)#

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