Label: SALINE LAXATIVE- sodium phosphate enema

  • NDC Code(s): 0363-0005-11, 0363-0005-20, 0363-0005-36, 0363-0005-37, view more
    0363-0005-38, 0363-0005-39, 0363-0005-40
  • Packager: Walgreen Company
  • 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 March 25, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 59 ml delivered dose)Purpose
    Dibasic Sodium Phosphate 3.5gSaline laxative
    Monobasic Sodium Phosphate 9.5gSaline laxative
  • Use

    • 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 the child

    • has already used a laxative for more than 3 days
    • has kidney disease, have heart problems, or is dehydrated
    • is on a sodium-restricted diet
    • has abdominal pain, nausea, or vomiting
    • has a sudden change in bowel habits lasting more than 2 weeks

    Ask a doctor or pharmacist before use if the child is 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 the child

    • has rectal bleeding
    • has no bowel movement within 30 minutes of enema use
    • has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

    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.

    children 2 to under 12 years of ageUse 1 bottle once daily
    children under 2 years of ageDO NOT USE
  • Other information

    • each 59 mL contains sodium 2.2g
    • 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?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 67 mL Bottle Box

    Walgreens

    Compare to Fleet®
    Pedia-Lax® Enema
    active ingredients††

    NDC 0363-0005-40

    READY-TO-USE
    Pediatric
    Enema
    SALINE LAXATIVE

    SALINE LAXATIVE
    PRE-MIXED

    • For relief of
      occasional
      constipation
    • Comfortable,
      lubricated tip
    • Not made
      with natural
      rubber latex

    NOT ACTUAL SIZE

    2.25 FL OZ (67 mL)

    Principal Display Panel - 67 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    SALINE LAXATIVE 
    sodium phosphate enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0005
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 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:0363-0005-371 in 1 BOX03/11/2016
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-0005-383 in 1 BOX03/11/2016
    2133 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:0363-0005-396 in 1 BOX03/11/2016
    3133 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    4NDC:0363-0005-111 in 1 BOX08/31/201203/11/2016
    4133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0005-363 in 1 BOX08/31/201203/11/2016
    5133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0363-0005-206 in 1 BOX08/31/201203/11/2016
    6133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0363-0005-4024 in 1 BOX08/31/201203/11/2016
    766.5 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 finalpart33408/31/2012
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(0363-0005)
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