Pro-enema Single Saline Enema
FDA Label NDC 71451-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Propharma Medical Supplies for the product Pro-enema Single Saline (NDC 71451-001). 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, dosage warning, ask a doctor before use if you, ask a doctor before using any laxative if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

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

Use

Relieves occasional constipation

Dosage Warning

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

For rectal use only.

Ask A Doctor Before Use If You

  • already used a laxative for more than 1 week
  • have kidney disease
  • have heart problems
  • are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet

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

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

Stop Use And Ask A Doctor If

  • you have bleeding
  • the condtion worsens or does not improve within 7 days
  • 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.

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. If swallowed, get medical help or contact a Poison Control Center right away:

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 old and older1 bottle once daily
Children 2 to under 12 years old1/2 bottle once daily
Children under 2 yearsDO NOT USE

Other Information

  • each 118 ml contains 4.4 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • this product generally produces a bowel movement in 1 to 5 minutes
  • carton sealed for safety. Do not use if top or bottom flap of the carton is torn or missing

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 133 Ml Bottle Carton

NDC 00000-000-00

*Compare To Fleet®

Ready-to-Use
Pro-Enema
Saline

Latex
Free

For relief of
occasional
constipation

1 Bottle
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.