LEADER MINERAL OIL- mineral oil enema

Leader Mineral Oil by

Drug Labeling and Warnings

Leader Mineral Oil by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

• for relief of occasional constipation

Warnings

For rectal use only

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
• you need to use a laxative for more than one week

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

Keep out of reach of children.

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

Directions

Single daily dose

• 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

How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Knee-chest position:

Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Administering enema:

• With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
• Do not force the enema tip into rectum as this can cause injury.
• Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
• Remove enema tip from rectum.
• Retain enema in accordance with doctor's instructions.

Other Information

• store at room temperature 20-25 deg C (68-77 deg F)
• this product generally produces bowel movement in 2-15 minutes

Inactive ingredient

none

Questions or comments?

1-800-633-5463

Principal Display Panel

Leader

Compare to Fleet® Mineral Oil Enema active ingredient

Ready-To-Use

Enema Mineral Oil

Sodium Free Lubricant

Laxative For Relief

of Occasional Constipation

Comfortable, Lubricated Tip

Works In Minutes

Latex Free

Satisfaction Guaranteed

4.5 FL OZ (133ml)

Side and Back Panel - Box

INGREDIENTS AND APPEARANCE

LEADER MINERAL OIL 
mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-755
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 mL  in 118 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-755-11	1 in 1 BOX
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, INC. (097537435)