Leader Ready to Use Mineral Oil Laxative: Package Insert and Label Information

LEADER READY TO USE MINERAL OIL LAXATIVE- mineral oil enema
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

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

Warnings

For rectal use only

Ask a doctor before use

• 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

• 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.

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

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

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

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

Inactive ingredients

none

Questions or comments?

1-866-323-0107

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL — 133 mL Bottle Carton

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)

LEADER READY TO USE MINERAL OIL LAXATIVE mineral oil enema

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0109 Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (MINERAL OIL) MINERAL OIL 118 g in 118 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70000-0109-1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 133 mL in 1 BOTTLE This package is contained within the CARTON (70000-0109-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 02/19/2013

Labeler — Cardinal Health (063997360)

Establishment
Name	Address	ID/FEI	Operations
Natureplex LLC		062808196	MANUFACTURE (70000-0109)

Revised: 06/2021 Cardinal Health