LEADER ENEMA- saline enema

Leader Enema by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 over:

  one bottle once daily

• children 2 to under 12 years:

  ½ bottle once daily

• children under 2 years:

  do 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.

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 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

Principal Display Panel

Leader

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)

Package Label - Back and Side Label with Drug Facts

INGREDIENTS AND APPEARANCE

LEADER ENEMA 
saline enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-754
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, DIBASIC	7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM PHOSPHATE, MONOBASIC	19 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-754-11	1 in 1 CARTON
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 37205-754-36	2 in 1 CARTON
2		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)