LEADER READY TO USE MINERAL OIL LAXATIVE- mineral oil enema

Leader Ready to Use Mineral Oil by

Drug Labeling and Warnings

Leader Ready to Use Mineral Oil by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	118 g  in 118 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0109-1	1 in 1 CARTON	02/19/2013
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product

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 (097537435)

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