LEADER ENEMA- mineral oil enema 
CARDINAL HEALTH, INC.

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.

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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

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

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.

Hand Positioning

Positioning:

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

Left-side Positioning

Knee-chest position:

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

Knee-chest Positioning

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

4.5 FL OZ (133ml)

Principal Display Panel

Side and Back Panel - Box

Side and Back Panel
LEADER ENEMA 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-755
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL118 mL  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-755-111 in 1 BOX
1133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/19/2013
Labeler - CARDINAL HEALTH, INC. (097537435)

Revised: 2/2013
 
CARDINAL HEALTH, INC.