FDA.reportPublic FDA data

NP Enema Non-Penetrating Safety Tip Saline

Manufacturer
Sterilab, Inc. | Pure Source, LLC
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-02 01:04:04

Label at a glance#

ProductNP Enema Non Penetrating Safety Tip Saline
Active ingredientSODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM, SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

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

Dosage and administration

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 bec...

Label contents#

Full prescribing information#

Active ingredients (In each 118 mL delivery dose)

OTC - ACTIVE INGREDIENT SECTION

Monobasic Sodium Phosphate 19 g
Dibasic Sodium Phosphate 7 g

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - STOP USE SECTION

• 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

OTC - ASK DOCTOR SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Disodium EDTA, Benzalkonium Chloride

Questions?

OTC - QUESTIONS SECTION

1-800-849-5909

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelInner LabelInner Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqrcodes.pro/c1L38bOuter Label.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85931-01885931-018-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWACTIB
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74ACTIB
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.