Label: SALINE ENEMA- 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 01/14

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

  • ACTIVE INGREDIENT

    Active Ingredient

    ( in each 118 mL delivered dose)

    Dibasic sodium phosphate 7g

    Monobasic sodium phosphate 19g

    Purpose

    Saline laxative

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  • Uses:

    • Gentle relief of occasional constipation
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  • Warnings:

    For rectal use only

    Dosage Warning: Using more than one enema in 24 hours can be harmful.

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  • As a doctor before use if you have:

    • a sodium-restricted diet
    • abdominal pain, nausea or vomiting
    • kidney disease, heart problems, or are dehydrated
    • notice a sudden change in bowel habits that persists over a period of 2 weeks

    • If pregnant or breast feeding, ask a health professional before use.

    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.

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  • Stop use and ask a doctor if:

    • If you have rectal bleeding
    • you have no bowel movement after use of a laxative. This may indicate a serious condition
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  • Keep out of reach of children

    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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  • Other information:

    • Each 118 mL contains: Sodium 4.3 g
    • Store at room temperature 15 Deg C - 30 Deg C (59 Deg F - 86 Deg F)
    • This product generally produces bowel movement in 15 minutes.
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  • Directions

    Do not use more unless directed by a doctor

    See Warnings

    Adults and children 12 years and older - 1 bottle

    Children 2 to under 12 years - 1/2 bottle

    Children under 2 years - Do not use. Consult a physician.

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  • Inactive ingredient

    Water

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  • Indications and Usage

    • For relief of occasional constipation

    When using this product

    • Do not exceed recommended dose unless directed by a doctor. Serious side effects may occur from excess dosage.
    • Do not use more than three days.

    Use of this product:

    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.

    Positioning

    Left-side position: ´╗┐Lie on left side with knees bent and arms at rest. (see diagram on box)

    Knee-chest position: ´╗┐Kneel, then lower headand chest forward until left side of face is resting on surface. Position arms comfortably. (see diagram on box)

    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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  • Principal Display Panel

    Saline enema

    Saline enema.jpg

    Saline enema

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  • INGREDIENTS AND APPEARANCE
    SALINE ENEMA 
    sodium phosphate monobasic, sodium phosphate dibasic enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-402
    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
    WATER  
    BENZALKONIUM CHLORIDE  
    EDETATE DISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-402-01 1 in 1 BOX
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/29/2012
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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