Label: LEADER READY TO USE SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
- NDC Code(s): 70000-0108-1, 70000-0108-2
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 22, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
Ask a doctor before use if you
- have already used a laxative for more than 3 days
- have kidney disease, have heart problems, or are dehydrated
- are 55 years of age or older
- are on a sodium-restricted diet
- have abdominal pain, nausea, or vomiting
- have a sudden change in bowel habits lasting more than 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, without asking a doctor
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Directions (or as directed by a doctor)
Single daily dosage (per 24 hours)
Do not use if taking another sodium phosphate product.
Do not use more unless directed by a doctor. See Warnings.
Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
LEADER ™
NDC 70000-0108-1
Ready-To-Use
Saline
Enema
Dibasic Sodium Phosphate, 7 g
Monobasic Sodium Phosphate, 19 g
Saline LaxativeFor Relief of
Occasional
ConstipationNot Made
with Natural
Rubber LatexCOMPARE TO
FLEET® SALINE
ENEMA
active ingredients*1 BOTTLE
100% Money
Back Guarantee4.5 FL OZ (133 mL)
-
INGREDIENTS AND APPEARANCE
LEADER READY TO USE SALINE LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enemaProduct 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, Unspecified Form (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Dibasic, Unspecified Form 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 (063997360) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(70000-0108)