FDA Label for Ready-to-use
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 118 ML DELIVERED DOSE)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE:
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT, DO NOT USE MORE THAN DIRECTED.
- 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?
- PRINCIPAL DISPLAY PANEL
Ready-to-use Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories, Inc.. 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 Ingredient (In Each 118 Ml Delivered Dose)
Sodium Phosphate (Monobasic 19 g and Dibasic 7 g)
Purpose
Saline Laxative
Uses
- relieves occasional constipation
- generally produces bowel movement in 2 to 5 minutes
- preparing patient for surgery
- preparing colon for x-ray endoscopic examination.
Professional use: bowel cleansing regimen for:
Warnings
For rectal use only
Dosage warning: Using more than one enema in 24 hours can be harmful
Do Not Use:
- if you are on a low salt diet
- when abdominal pain, nausea or vomiting are present
- for a period longer than 1 week
- in patients with megacolon (as hypernatremic dehydration may occur)
Ask A Doctor Before Use If You Have:
- kidney disease or impaired renal function
- 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.
Stop Use And Ask A Doctor If
- symptoms last more than 2 weeks
- you have rectal bleeding or fail to have a bowel movement after using this product. This 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.
Directions
- remove enema tip from plastic wrap
- to open, hold enema bottle in upright position at its neck and twist off tab
- screw enema tip securely onto open bottle
- remove green protective shield from tip before using
- with steady pressure, gently insert enema into rectum with tip pointing toward the navel
- squeeze bottle until recommended dose is expelled (It is not necessary to empty unit completely. Bottle contains more liquid than needed for effective use. A small amount of liquid will remain in bottle after squeezing.)
- remove tip from rectum
- discontinue use if resistance is encountered, forcing the enema can result in injury
- maintain position until urge to evacuate is strong (usually 2 to 5 minutes)
Do not use more unless directed by a doctor. See Warnings.
adults & children 12 years and older | one bottle once daily |
children 2 to under 12 years | ½ bottle once daily |
children under 2 years | do not use |
Positioning
Left side position: Lie on left side with knee bent and arms at rest.
Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
Administering Enema:
Other Information
- each 118 mL contains: sodium 4.4 g
- bottle, cap and shield are LATEX FREE
- store at room temperature 15° - 30° C (59° - 86° F)
Inactive Ingredients
benzalkonium chloride, disodium EDTA and purified water.
Questions Or Comments?
Call 1-800-645-2158
9 am - 5 pm ET, Monday - Friday
Principal Display Panel
Principal Package Display
* Please review the disclaimer below.