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

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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Leader Ready to Use Saline Enema
Laxative

Drug Facts

Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative

Use

Warnings

Dosage warning

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

For rectal use only.

Do not use

  • on children under 2 years of age

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

Stop use and ask a doctor if

  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate 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: 800-222-1222.

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 older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO NOT USE

Other information

Inactive ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions or comments?

866-323-0107

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

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 Laxative

For Relief of
Occasional
Constipation

Not Made
with Natural
Rubber Latex

COMPARE TO
FLEET® SALINE
ENEMA
active ingredients*

1 BOTTLE

100% Money
Back Guarantee

4.5 FL OZ (133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
LEADER READY TO USE SALINE   LAXATIVE
sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0108
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Dibasic, Unspecified Form7 g  in 118 mL
Sodium Phosphate, Monobasic, Unspecified Form (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Unspecified Form19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0108-11 in 1 CARTON02/19/2013
1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0108-22 in 1 CARTON02/19/2013
2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/19/2013
Labeler - Cardinal Health (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(70000-0108)

Revised: 6/2021
Document Id: fbed22ae-8e60-422a-a89b-fc7b907049d6
Set id: 1b4f9c28-0547-4922-aa15-990c6fd9dc9f
Version: 3
Effective Time: 20210622
 
Cardinal Health