Label: SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic enema

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    (in each 118 mL delivered dose)

    Dibasic sodium phosphate 7 g

    Monobasic sodium phosphate 19 g

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  • Purpose

    Saline laxative

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  • Uses

    • relieves occasional constipation
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  • 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 may be signs of a serious condition.

    If pregnant or breastfeeding, 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)

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  • 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

    1/2 bottle once daily

    children under

    2 years

    do not use

    CAUTION:

    Remove green protective shield before inserting. Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.

    Remove protective shield illustration

    Positioning:

    Left-side position: lie on left side with knee bent and arms at rest.

    Left Side position illustration

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

    Knee-chest position illustration

    Administering enema:

    • with steady pressure, gently insert enema with tip pointing toward 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
    • stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
    • maintain position until urge to evacuate is strong (usually 1 to 5 minutes)
    • if no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
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  • Other Information

    • each 118 mL contains: sodium 4.3 g
    • store at room temperature 20-25 deg C (68-77 deg F)
    • this product generally produces bowel movement in 1 to 5 minutes
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  • Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water

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  • Questions or comments?

    1-800-633-5463

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  • Side and Principal Display Panel - box

    Cardinal Health Saline Laxative Enema box principal display panel

    QTY 1EA

    Cat. 20306-010

    NDC 63517-005-11

    Ready-to-Use

    ENEMA

    Saline Laxative

    For relief of occasional constipation

    Pre-mixed

    Lubricated Tip

    Single Pack

    Latex Free

    Cardinal Health

    4.5 fl oz (133 ml)

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  • Side and Back - box
  • INGREDIENTS AND APPEARANCE
    SALINE LAXATIVE 
    sodium phosphate enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63517-005
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC 7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC 19 g  in 118 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    EDETATE DISODIUM  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63517-005-11 1 in 1 BOX
    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 08/31/2012
    Labeler - Cardinal Health (097537435)
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