Np Enema Non Penetrating Safety Tip Saline Liquid
FDA Label NDC 85931-018

14 label sections · Submitted to the FDA by Sterilab, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sterilab, Inc. for the product Np Enema Non Penetrating Safety Tip Saline (NDC 85931-018). 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 drug facts, active ingredients (in each 118 ml delivery dose), purpose, uses, warnings:, do not use, stop use and ask a doctor if, ask a doctor before use if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each 118 Ml Delivery Dose)

Monobasic Sodium Phosphate 19 g
Dibasic Sodium Phosphate 7 g

Purpose

Saline laxative

Uses

  • For relief of occasional constipation.
  • Generally produces a bowel movement in 1 to 5 minutes.

Warnings:

Using more than one enema in 24 hours can be harmful.
For rectal use only.

Do Not Use

• For more than 3 days. •If you have kidney disease, heart failure, are dehydrated, or are on a low-sodium diet, unless directed by a doctor. • If you have abdominal pain, nausea, or vomiting, unless directed by a doctor. •In children under 12 years of age, unless directed by a doctor.

Stop Use And Ask A Doctor If

• You have rectal bleeding. • You do not have a bowel movement after use.
Symptoms of dehydration (feeling thirsty, dizziness, vomiting, urinating less than normal).
These symptoms may indicate a serious condition.

Ask A Doctor Before Use If You

  • Are 55 years of age or older.
  • Are on a sodium-restricted diet.
  • Have a sudden change in bowel habits lasting more than 2 weeks.
  • Already used a laxative for more than 1 week.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

Single Daily Dosage (per 24h)
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 and over 1 bottle per day
 Children 2 to 11 years Ask a doctor
 Children under 2 years DO NOT USE

If urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Other Information:

  • Each 118 mL delivered dose contains: sodium 4.4 g.
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Water (Aqua), Disodium EDTA, Benzalkonium Chloride

Questions?

1-800-849-5909

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