Saline Enema

Manufacturer
Galentic Pharma (India) Priva Te Ltd.
Effective date
2013-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:36:28

Label at a glance#

ProductSaline Enema
Active ingredientSODIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, MONOBASIC
Label structure11 sections

Indications and uses

Gentle relief of occasional constipation

Dosage and administration

Do not use more unless directed by a doctor See Warnings Adults and children 12 years and older - 1 bottle Children 2 to under 12 years - 1/2 bottle Children under 2 years - Do not use. Consult a physician.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

( in each 118 mL delivered dose)

Dibasic sodium phosphate 7g

Monobasic sodium phosphate 19g

Purpose

Saline laxative

Uses:

OTC - PURPOSE SECTION

  • Gentle relief of occasional constipation

Warnings:

WARNINGS SECTION

For rectal use only

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

As a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • a sodium-restricted diet
  • abdominal pain, nausea or vomiting
  • kidney disease, heart problems, or are dehydrated
  • notice a sudden change in bowel habits that persists over a period of 2 weeks
  • If pregnant or breast feeding, ask a health professional before use.

Ask a doctor or pharmacist before use if you are

  • taking any other drug
  • take this product two or more hours before or after other drugs

Laxatives may affect how other drugs work.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • If you have rectal bleeding
  • you have no bowel movement after use of a laxative. This may indicate a serious condition

Keep out of reach of children

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. (1-800-222-1222)

Other information:

OTHER SAFETY INFORMATION

  • Each 118 mL contains: Sodium 4.3 g
  • Store at room temperature 15 Deg C - 30 Deg C (59 Deg F - 86 Deg F)
  • This product generally produces bowel movement in 15 minutes.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more unless directed by a doctor

See Warnings

Adults and children 12 years and older - 1 bottle

Children 2 to under 12 years - 1/2 bottle

Children under 2 years - Do not use. Consult a physician.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water

Indications and Usage

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation

When using this product

  • Do not exceed recommended dose unless directed by a doctor. Serious side effects may occur from excess dosage.
  • Do not use more than three days.

Use of this product:

CAUTION: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING

Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

Positioning

Left-side position: Lie on left side with knees bent and arms at rest. (see diagram on box)

Knee-chest position: Kneel, then lower headand chest forward until left side of face is resting on surface. Position arms comfortably. (see diagram on box)

Administering Enema

  • With steady pressure, gently insert enema with tip pointing toward navel.
  • Squeeze bottle until recommended dose is expelled ( it is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing).
  • Remove tip from rectum.
  • Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
  • Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).
  • If no 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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gal Saline Enema.jpg

Saline enema

Saline enemaSaline enema

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN2
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD2
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY2
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50382-002-012019-11-27C16284748780-19855d018-d358-cd31-e053-dbdaa90ab51aEnema, Saline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-002-01Saline Enema118 mL in 1 BOTTLEENEMA1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-002SALINE ENEMA ENEMA [GALENTIC PHARMA (INDIA) PRIVA TE LTD.]2Legacy NDC, 1 package rows20130808_619f934e-ac71-4447-a17b-1a30d1073b36.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA742
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SW2
PHOSPHATE IONACTIVE MOIETYNK08V8K8HR2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-00250382-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

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
43a17fc1-50a5-4be9-85d2-b0d7ed36be2b619f934e-ac71-4447-a17b-1a30d1073b362013-08-08WarningsExact identifier
spl id: 43a17fc1-50a5-4be9-85d2-b0d7ed36be2b
spl set id: 619f934e-ac71-4447-a17b-1a30d1073b36

Reported adverse events (FAERS/openFDA)#

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