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Ready-to-Use

Rugby Laboratories, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 118 mL delivered dose)

Sodium Phosphate (Monobasic 19 g and Dibasic 7 g)

Purpose

Saline Laxative

Ready-to-Use Uses

  • relieves occasional constipation
  • generally produces bowel movement in 2 to 5 minutes

 

Professional use: bowel cleansing regimen for:

  • preparing patient for surgery
  • preparing colon for x-ray endoscopic examination.

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
Ready-to-Use
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:

  • 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)

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

Ready-to-Use
Principal Package Display

Ready-to-Use

Sodium Phosphate ENEMA

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-7415
Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM PHOSPHATE, DIBASIC 7 g
sodium phosphate, monobasic 19 g

Inactive Ingredients

Ingredient Name Strength
benzalkonium chloride
EDETATE DISODIUM
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 133 in 1 BOTTLE
2 NDC:0536-7415-51 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-09-01


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Be sure to consult your doctor before taking any medication!
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