Saline Laxative
MAJOR SALINE ENEMA LAXATIVE
b3758ffe-1bac-4df6-9714-5e33e9d28d90
HUMAN OTC DRUG LABEL
Sep 16, 2025
Major Pharmaceuticals
DUNS: 191427277
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Saline Laxative
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
PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
MAJOR®
NDC 0904-6320-78
Compare to the
active ingredients of
Fleet® Saline Enema*
Ready-to-Use
Enema
Saline Laxative
For relief of occasional
constipation
Not made with natural
rubber latex
4.5 FL OZ (133 mL)
1 Bottle
INDICATIONS & USAGE SECTION
Use
▪
relieves occasional constipation
▪
this product generally produces bowel movement in 1 to 5 minutes
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR**®**** PHARMACEUTICALS**
Livonia, MI 48152
OTC - ACTIVE INGREDIENT SECTION
|
Active ingredients (in each 118mL delivered dose) |
Purpose |
|---|---|
|
Dibasic Sodium Phosphate 7 g |
Saline laxative |
|
Monobasic Sodium Phosphate 19 g |
Saline laxative |
WARNINGS SECTION
Warnings
Dosage warning
Using more than one enema in 24 hours can be harmful.
For rectal use only.
Do not use
▪
on children under 2 years of age
Ask a doctor before use if you
▪
have already used a laxative for more than 3 days
▪
have kidney disease, have heart problems, or are dehydrated
▪
are 55 years of age or older
▪
are on a sodium-restricted diet
▪
have abdominal pain, nausea, or vomiting
▪
have a sudden change in bowel habits lasting more than 2 weeks
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.
When using this product
▪
**do not use more than directed. Serious side effects may occur from excess dosage**
▪
do not use for more than 3 days, without asking a doctor
Stop use and ask a doctor if
▪
you have rectal bleeding
▪
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.
DOSAGE & ADMINISTRATION SECTION
Directions (or as directed by a doctor)
Single daily dosage (per 24 hours)
Do not use if taking another sodium phosphate product.
Do not use more unless directed by a doctor. SeeWarnings.
|
Adults and children 12 years of age and older |
1 bottle once daily |
|
Children 2 to under 12 years of age |
Use Pediatric Enema |
|
Children under 2 years of age |
DO NOT USE |
STORAGE AND HANDLING SECTION
Other information
▪
**each 118 ml contains** sodium 4.3 g
▪
store at 15 to 30°C (59 to 86°F)
▪
additional liquids by mouth are recommended while using this product
▪
**Tamper Evident:** DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzalkonium chloride, disodium EDTA, purified water
OTC - QUESTIONS SECTION
Questions or comments?
(800) 616-2471