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NATUREPLEX (Natureplex, LLC)

Available Formats

Dosage Form Package Information Links
ENEMA 1 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-01) > 133 mL in 1 BOTTLE, WITH APPLICATOR Label Information
ENEMA 2 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-02) > 133 mL in 1 BOTTLE, WITH APPLICATOR Label Information
ENEMA 3 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-03) > 133 mL in 1 BOTTLE, WITH APPLICATOR Label Information

Complete NATUREPLEX Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each 118mL delivered dose) Purpose
    Dibasic Sodium Phosphate 7 g Saline laxative
    Monobasic Sodium Phosphate 19 g Saline laxative

  • Use

    Relieves occasional constipation


  • 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
    • already used a laxative for more than 1 week
    • have kidney disease
    • have heart problems
    • are dehydrated
    • are 55 years old or older
    • are on a sodium-restricted diet

    Ask a doctor before using any laxative if you have
    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

    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 bleeding
    • the condtion worsens or does not improve within 7 days
    • you have no bowel movement within 30 minutes of enema use
    • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

    These symptoms 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: 800-222-1222.


  • Directions

    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 and children 12 years old and older 1 bottle once daily
    Children 2 to under 12 years old 1/2 bottle once daily
    Children under 2 years DO NOT USE

  • Other information

    • each 118 ml contains 4.3 g sodium
    • store at 15 to 30°C (59 to 86°F)
    • additional liquids by mouth are recommended while using this product
    • this product generally produces a bowel movement in 1 to 5 minutes
    • carton sealed for safety. Do not use if top or bottom flap of the carton is torn or missing

  • Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water


  • Questions or comments?

    866-323-0107 or www.natureplex.com


  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    NDC 67234-020-01

    *Compare To Fleet®

    Natureplexâ„¢

    READY TO USE

    Enema

    Saline

    For
    Relief Of
    Occasional
    Constipation

    Latex
    Free

    Soft,
    Easy To
    Use
    Bottle

    1
    Bottle
    4.5 Fl Oz
    (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    NATUREPLEX  ENEMA
    (saline) enema
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-020
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g  in 133 mL
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g  in 133 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:67234-020-01 1 in 1 CARTON 06/01/2010
    1 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2 NDC:67234-020-02 2 in 1 CARTON 06/01/2010
    2 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    3 NDC:67234-020-03 3 in 1 CARTON 06/01/2010
    3 133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/01/2010
    Labeler - Natureplex, LLC (062808196)
    Establishment
    Name Address ID/FEI Business Operations
    Natureplex, LLC 062808196 manufacture(67234-020)