FDA Label for Saline Laxative
View Indications, Usage & Precautions
- 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
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Saline Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 118 Ml Delivered Dose)
Dibasic sodium phosphate 7 g
Monobasic sodium phosphate 19 g
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
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