FDA.reportPublic FDA data

Pro-Enema Single Saline

Manufacturer
Propharma Medical Supplies
Effective date
2017-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:50:06

Label at a glance#

ProductPro-Enema Single Saline Laxative
Active ingredientSodium Phosphate, Dibasic, SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Label structure9 sections

Dosage and administration

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 older 1 bottle once daily Children 2 to under 12 years old 1/2 bottle once daily Children under 2 years DO NOT USE

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Use

INDICATIONS & USAGE SECTION

Relieves occasional constipation

Warnings

WARNINGS SECTION

Dosage warning

SPL UNCLASSIFIED SECTION

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

For rectal use only.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away:

Directions

DOSAGE & ADMINISTRATION SECTION

Single daily dosage (per 24 hours)

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium EDTA, purified water

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN1
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD1
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY1
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71451-001-01Pro-Enema Single Saline Laxative133 mL in 1 BOTTLE, WITH APPLICATORENEMA1331
71451-001-01Pro-Enema Single Saline Laxative1 in 1 CARTONENEMA11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71451-001PRO-ENEMA SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [PROPHARMA MEDICAL SUPPLIES]1Current NDC, Legacy NDC, 2 package rows20170613_e53c5eda-21da-4aed-a592-315100167cc2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71451-00171451-001-01

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, DibasicGR686LBA74ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pro-Enema Single Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMPropharma Medical Suppliese53c5eda-21da-4aed-a592-315100167cc22017-06-08WarningsExact identifier
ndc (package): 71451-001-01
ndc (product): 71451-001
ndc11 (package): 71451000101
spl id: dc3d1fb9-2926-43fc-b39a-2248e8ce0451
spl set id: e53c5eda-21da-4aed-a592-315100167cc2

Reported adverse events (FAERS/openFDA)#

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