Leader Ready To Use Saline Enema
FDA Label NDC 70000-0108

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Ready To Use Saline (NDC 70000-0108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, warnings, dosage warning, ask a doctor before use if you, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

Otc - Purpose

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

Otc - Ask Doctor/Pharmacist

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 overone bottle once daily
children 2 to under 12 years1/2 bottle once daily discard unused portion
children under 2 yearsDO 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

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)

Principal Display Panel (133 ml Bottle Carton)

Principal Display Panel (133 ml Bottle Carton)

* Please review the disclaimer below.