Pediatric
FDA Label NDC 67234-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureplex, Llc for the product Pediatric (NDC 67234-042). 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, active ingredients (in each 59 ml delivered dose), purpose, use, warnings, dosage warning, ask a doctor or pharmacist before using if the child, 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

Active Ingredients (In Each 59 Ml Delivered Dose)

Dibasic Sodium Phosphate 3.5g
Monobasic Sodium Phosphate 9.5g

Purpose

Saline laxative
Saline laxative

Use

Relieves occasional constipation

Warnings

For rectal use only

Dosage Warning

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

Ask A Doctor Or Pharmacist Before Using If The Child

  • has a sodium-restricted diet
  • has abdominal pain, nausea, or vomiting
  • has kidney disease, heart problems, or dehydration
  • has a sudden change in bowel habits that lasts over 2 weeks
  • already used a laxative for more than 1 week
  • is 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

Stop Use And Ask A Doctor If The Child Has

  • rectal bleeding
  • no bowel movement after use of a laxative
  • symptoms of dehydration such as thirst, dizzyness, or urinating less frequently than normal

    • These could be symptoms of a serious condition.

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: 800-222-1222.

Directions

Single daily dosage (per 24 hours)

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

children 2 to 11 years1 bottle once daily
children under 2 yearsask a doctor

Other Information

  • each 59 mL contains: sodium 2.2g
  • store at 15 to 30°C (59 to 86°F)
  • this product generally produces a bowel movement in 1 to 5 minutes

Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 67 Ml Bottle Carton

Natureplex™

pediatric
ages 2-11

NDC 67234-042-01

E
N
E
M
A

*Compare
To
Fleet®

saline laxative

  • Latex Free
  • Pre-mixed
  • For relief of
    occasional
    constipation
  • Pre-lubricated
    tip

    • 1
    Bottle
    2.25 Fl Oz
    (67 mL)

    Principal Display Panel (67 mL Bottle Carton)

    Principal Display Panel (67 mL Bottle Carton)

* Please review the disclaimer below.