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Ready-to-Use (Rugby Laboratories, Inc.)

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ENEMA 1 BOTTLE in 1 CARTON (0536-7415-51) > 133 mL in 1 BOTTLE Label Information

Complete Ready-to-Use Information

  • 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
    Illustration #1

    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.

    Illustration #2

    Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

    Illustration #3

    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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    Package Display

    Principal Package Display


  • INGREDIENTS AND APPEARANCE
    READY-TO-USE 
    sodium phosphate enema
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-7415
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHORIC ACID - UNII:E4GA8884NN) SODIUM PHOSPHATE, DIBASIC 7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHORIC ACID - UNII:E4GA8884NN) SODIUM PHOSPHATE, MONOBASIC 19 g  in 118 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-7415-51 1 in 1 CARTON
    1 133 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 09/01/2011
    Labeler - Rugby Laboratories, Inc. (109178264)