Saline Enema
4719 Enema, Saline NDC 67777-402-01
7c7b68af-4ef2-4f84-9279-9f7a91c8d9c5
HUMAN OTC DRUG LABEL
May 14, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label
4719
Enema Saline Laxative
INDICATIONS & USAGE SECTION
Uses
• For relief of occasional constipation
• This product generally produces bowel movement in 2 to 15 minutes
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
( in each 118 mL delivered dose)
Dibasic Sodium Phosphate 7g
Monobasic Sodium Phosphate 19g
OTC - PURPOSE SECTION
Purpose
Saline Laxative
WARNINGS SECTION
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
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
Other information:
- Sodium content in each dose (1 bottle): 4.4 g
- Store at room temperature 15º-30ºC (59º- 8ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Benzalkonium Chloride, Disodium EDTA, Purified Water
OTC - QUESTIONS SECTION
Questions?
1-888-DYNAREX Monday - Friday 9AM - 5PM EST