MedPath

Saline Enema

4719 Enema, Saline NDC 67777-402-01

Approved
Approval ID

7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

Dynarex Corporation

DUNS: 008124539

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Phosphate Monobasic, Sodium Phosphate Dibasic

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67777-402
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium Phosphate Monobasic, Sodium Phosphate Dibasic
Product Specifications
Route of AdministrationRECTAL
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (5)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICActive
Quantity: 7 g in 118 mL
Code: GR686LBA74
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASICActive
Quantity: 19 g in 118 mL
Code: 3980JIH2SW
Classification: ACTIB
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/28/2013

Label

4719 IN MASTER4719 Enema Saline Laxative

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/28/2013

Uses

• For relief of occasional constipation

• This product generally produces bowel movement in 2 to 15 minutes

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/28/2013

Active Ingredients

( in each 118 mL delivered dose)

Dibasic Sodium Phosphate 7g

Monobasic Sodium Phosphate 19g

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/28/2013

Purpose

Saline Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 2/28/2013

Warnings:

For rectal use only

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

Do not use

• Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

• Longer than 1 week unless directed by a doctor

• This product if you are on a low salt diet unless directed by a doctor

• This product if you have kidney disease unless directed by a doctor

Ask a doctor before use if you have:

Noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if:

  • If you have rectal bleeding or fail to have a bowel movement after use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/28/2013

Directions

Adults and children 12 years old and over - 1 bottle once daily

Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion

Children under 2 years - Consult a physician.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/28/2013

Other information:

  • Sodium content in each dose (1 bottle): 4.4 g
  • Store at room temperature 15º-30ºC (59º- 8ºF)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/28/2013

Inactive ingredients

Benzalkonium Chloride, Disodium EDTA, Purified Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/28/2013

Questions?

1-888-DYNAREX Monday - Friday 9AM - 5PM EST

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Saline Enema - FDA Drug Approval Details