PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]

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PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.]
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NDC 53329-014-11, 53329-014-58
Set ID e3165538-75dd-4f0f-adc8-d4075de10f1e
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient

    (in each 118 mL delivered dose)

    Dibasic sodium phosphate 7 g

    Monobasic sodium phosphate 19 g

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation
    • this product generally produces bowel movement in 1 to 5 minutes
  • Warnings

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

    For rectal use only.

    Do not use

    • on children under 2 years of age

    Ask a doctor before use if you

    • have already used a laxative for more than 3 days
    • have kidney disease, have heart problems, or are dehydrated
    • are 55 years of age or older
    • are on a sodium-restricted diet
    • have abdominal pain, nausea or vomiting
    • have a sudden change in bowel habits lasting more than 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, without asking a doctor

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you have no bowel movement within 30 minutes of enema use
    • you have symtoms of dehydration (thirstiness, dissiness, vomiting, urinating less oftan than normal)

    These symptoms may indicate 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.

  • Directions

    (or as directed by a doctor)

    Single daily dosage (per 24 hours)

    Do not use if taking another sodium phosphate product.

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

    adults & children

    12 years and over

    1 bottle once daily

    children 2 to under

    12 years

    Use Pediatric Enema

    children under

    2 years

    DO NOT USE

    CAUTION:Remove protective shield from enema tip 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

    Positions for using this enema:

    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 with left arm folded comfortably.

    Knee-chest position illustration

    Administering enema:

    • With steady pressure, gently insert enema tip into rectum with a slight side to side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. Doing so helps relax muscles around anus.
    • Do not force enema tip into 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.
    • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed.
    • Remove tip from rectum and stay in 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.
  • Other Information

    • each 118 mL contains sodium 4.3 g
    • store at15-30°C (59-86°F)
    • additional liquids by mouth are recommended while using this product
    • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING
  • Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions or comments?

    866-323-0107

  • Manufacturing Information

    Manufactured for: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE

    REF: CUR095005

    RC21NPX

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PURE AND GENTLE LAXATIVE 
    sodium phosphate enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-014
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-014-111 in 1 BOX11/10/2017
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:53329-014-5824 in 1 CASE11/03/2017
    2133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/09/2014
    Labeler - Medline Industries, LP (025460908)
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