LEADER ENEMA- sodium phosphate, dibasic and sodium phosphate, monobasic 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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Active ingredients (in each 118 mL delivered dose)

Dibasic sodium phosphate 7 g

Monobasic sodium phosphate 19 g

Purpose

Saline laxative

Uses

  • relieves occasional constipation

Warnings

For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful.

Ask a doctor before use if you have

  • a sodium-restricted diet
  • abdominal pain, nausea or vomiting
  • kidney disease, heart problems, or are dehydrated
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

  • do not use more than directed. Serious side effects may occur from excess dosage.
  • do not use for more than 3 days

Stop use and ask a doctor if

  • you have rectal bleeding
  • you have no bowel movement after use of a laxative

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Do not use more unless directed by a doctor. See Warnings.

adults & children 12 years and overone bottle once daily
children 2 to under 12 years½ bottle once daily
children under 2 yearsdo not use

Caution:

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 Position

Knee-chest position:

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

Knee-Chest Position

Administering enema:

  •  With steady pressure, gently insert enema with tip pointing toward navel
  • squeeze bottle until recommended dose is expelled (it is not necessary to empty until completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
  • Remove tip from rectum.
  • stop using if tip is hard to insert. Forcing the tip into rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
  • if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other information

  • each 118 mL contains: sodium 4.3 g
  • store at room temperature 20º-25ºC (68º-77ºF)
  • this product generally produces bowel movement in 1 to 5 minutes

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-800-367-4477

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Compare to Fleet® Enema Saline active ingredients

READY-TO-USE

Enema

Saline Laxative

For Relief Of Occasional Constipation

Soft, Flexible Comfort Tip

Latex Free

4.5 FL OZ (133ml)

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Package Label - Back and Side Label with Drug Facts

Back Panel and Side Panel with Drug Facts
LEADER ENEMA 
saline enema
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-754
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-754-111 in 1 CARTON
1133 mL in 1 BOTTLE
2NDC:37205-754-362 in 1 CARTON
2133 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.