Label: NATUREPLEX ENEMA (- saline enema

  • NDC Code(s): 67234-020-01, 67234-020-02, 67234-020-03
  • Packager: Natureplex, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 24, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 118mL delivered dose)Purpose
    Dibasic Sodium Phosphate 7 gSaline laxative
    Monobasic Sodium Phosphate 19 gSaline laxative
  • Use

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

    For rectal use only.

    Dosage warning

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

    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
    • 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 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 (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 and children 12 years of age and older1 bottle once daily
    Children 2 to under 12 years of ageUse Pediatric Enema
    Children under 2 years of ageDO 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
    • 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 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    NDC 67234-020-01

    *Compare To Fleet®

    Natureplex™

    READY TO USE

    Enema

    Saline

    Not Made
    with
    Natural
    Rubber
    Latex

    For
    Relief Of
    Occasional
    Constipation

    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-020
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g  in 133 mL
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 133 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:67234-020-011 in 1 CARTON06/01/2010
    1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:67234-020-022 in 1 CARTON06/01/2010
    2133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:67234-020-033 in 1 CARTON06/01/2010
    3133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/01/2010
    Labeler - Natureplex, LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex, LLC062808196manufacture(67234-020)
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