LEADER READY TO USE SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema

Leader Ready to Use Saline by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 118 mL delivered dose)	Purpose
Dibasic sodium phosphate 7 g	Saline laxative
Monobasic sodium phosphate 19 g	Saline laxative

Use

• for relief of 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

• are on a sodium-restricted diet
• have abdominal pain, nausea, or vomiting
• have kidney disease, heart problems, or are dehydrated
• are 55 years old or older
• have noticed a sudden change in bowel habits that lasts over 2 weeks
• have already used a laxative for more than 1 week

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
• do not use if taking another sodium phosphates product

Stop use and ask a doctor if you have

• rectal bleeding
• symptons of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)
• no bowel movement or no liquid comes out of the rectum after 30 minutes

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 to prevent accidental ingestion. 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.

Single daily dosage (per 24 hours).

• adults & children 12 years and over: one bottle once daily
• children 2 to under 12 years: 1/2 bottle once daily discard unused portion
• children under 2 years: DO NOT USE

Do not use if taking another sodium phosphates product.

Other information

• each 118 mL contains: sodium 4.4g
• store at room temperature 15°-30°C (59°-86°F)
• this product generally produces a bowel movement in 1 to 5 minutes
• additional liquids by mouth are recommended while taking this product

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

1-866-323-0107

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

NDC: 70000-0108-1

LEADER®

Compare to Fleet®
Saline Enema
active ingredients*

READY-TO-USE
Enema
Saline Laxative

For Relief Of
Occasional
Constipation

Soft, Flexible
Comfort Tip

Latex Free

SATISFACTION
GUARANTEED

4.5 FL OZ (133 ml)

INGREDIENTS AND APPEARANCE

LEADER READY TO USE SALINE   LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0108
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Phosphate, Dibasic (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	Sodium Phosphate, Dibasic	7 g  in 118 mL
Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR)	Sodium Phosphate, Monobasic, Unspecified Form	19 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0108-1	1 in 1 CARTON	02/19/2013
1		133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70000-0108-2	2 in 1 CARTON	02/19/2013
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 (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(70000-0108)