Active Ingredients (In Each 118 Ml Delivered Dose)
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g
Saline Laxative Enema
FDA Label NDC 0904-6320
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Saline Laxative (NDC 0904-6320). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 118 ml delivered dose), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative
Uses
- relieves occasional constipation
Warnings
For rectal use only
Dosage warning: Using more than one enema in 24 hours can be harmful.
Ask A Doctor Before Use If You Have
- a sodium-restricted diet
- abdominal pain, nausea or vomiting
- kidney disease, heart problems, or are dehydrated
- noticed a sudden change in bowel habits that lasts over 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
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you have no bowel movement after use of a laxative
These could be signs of 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. (1-800-222-1222)
Directions
Do not use more unless directed by a doctor. See Warnings.
| adults & children 12 years and over | one bottle once daily |
| children 2 to under 12 years | ½ bottle once daily |
| children under 2 years | do not use |
Other Information
- each 118 mL contains: sodium 4.3 g
- store at room temperature 20°-25°C (68°-77°F)
- this product generally produces bowel movement in 1 to 5 minutes
Inactive Ingredients
benzalkonium chloride, disodium EDTA, purified water
Questions Or Comments?
1-800-616-2471
Package/Label Principal Display Panel
Compare to the active ingredients in Fleet® Enema Saline
Ready-to-Use
ENEMA
SALINE LAXITIVE
LATEX FREE
For relief of occasional constipation
Soft, flexible
Comfort tip
* Please review the disclaimer below.
