Ready-to-use Enema
FDA Label NDC 11673-222

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Ready-to-use Enema (NDC 11673-222). 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 active ingredient (in each 118 ml delivered dose), purpose, use, warnings, ask a doctor before using this product if you:, ask a doctor before using any laxative if you have:, stop use and ask a doctor if you have:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 118 Ml Delivered Dose)

Sodium Phosphate 19 g

Dibasic Sodium Phosphate 7 g

Purpose

saline laxative & bowel cleanser

Use

 for relief of occasional constipation or bowel cleansing before rectal examinations

Warnings

For rectal use only

Dosage warning: Using more than one enema in 24 hours can be harmful

Ask A Doctor Before Using This Product If You:

  • Are on a sodium-restricted diet
  • Have kidney disease

Ask A Doctor Before Using Any Laxative If You Have:

  • Abdominal pain, nausea, or vomiting
  • A sudden change in bowel habits lasting more than 2 weeks
  • Already used a laxative for more than 1 week

Stop Use And Ask A Doctor If You Have:

  • Rectal bleeding
  • No bowel movement after the enema is given

    • 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.

When Using This Product, Do Not Use More Than Directed.

Serious side effects may occur from excess dosage.

Directions

One dose daily. Do not use more unless directed by a doctor. See Warnings.

adults & children 12 years and older1 Bottle
children under 12 yearsAsk your child's pediatrician
children under 2 yearsDO NOT USE

Other Information

  • Each 118 mL contains: sodium 4.4 g
  • This product generally results in a bowel movement in 1 to 5 minutes
  • Tamper Evident: If the bottle is open do not use
  • Consult PHYSICIAN DESK REFERENCE® for complete professional labeling.

Inactive Ingredients

Benzalkonium chloride, disodium EDTA and purified water

Questions Or Comments?

Call 1-877-545-3635

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