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Ready-to-Use

Dosage form: enema
Ingredients: SODIUM PHOSPHATE, DIBASIC 7g in 118mL, SODIUM PHOSPHATE, MONOBASIC 19g in 118mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-7415

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

 

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

Do not use more unless directed by a doctor. See Warnings.

adults & children 12 years and olderone bottle once daily
children 2 to under 12 years½ bottle once daily
children under 2 yearsdo 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

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READY-TO-USE 
sodium phosphate enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-7415
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM PHOSPHATE, DIBASIC (PHOSPHORIC ACID) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
SODIUM PHOSPHATE, MONOBASIC (PHOSPHORIC ACID) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:0536-7415-511 BOTTLE (BOTTLE) in 1 CARTON
1133 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/2011
Labeler - Rugby Laboratories, Inc. (109178264)

Revised: 09/2011
 
Rugby Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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