QUALITY CHOICE SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [CDMA]

QUALITY CHOICE SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [CDMA]
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NDC 63868-380-45, 63868-380-90
Set ID 64950e20-91a8-4914-81aa-850f1a027ca6
Category HUMAN OTC DRUG LABEL
Packager CDMA
Generic Name
Product Class
Product Number
Application Number PART334
  • 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

  • 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 more unless directed by a doctor. See Warnings.

    Do not use if taking another sodium phosphate product.

    Adults and children 12 years old and older1 bottle once daily
    Children 2 to under 12 years old1/2 bottle once daily
    Children under 2 yearsDO NOT USE
  • Other information

    • each 118 ml contains 4.4 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

  • SPL UNCLASSIFIED SECTION

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48376-0995

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    NDC# 63868-380-45

    QC®
    QUALITY
    CHOICE

    * Compare to the
    active ingredients
    in FLEET ® Enema

    Enema

    Relieves Occasional
    Constipation

    Complete, Ready-to-Use

    SODIUM PHOSPHATES
    RECTAL SOLUTION

    Latex Free

    Comfortable,
    Lubricated Tip

    Works In
    Minutes

    1
    Bottle
    4.5 Fl Oz (133 mL)

    Principal Display Panel - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE SINGLE SALINE   LAXATIVE
    sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-380
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) 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:63868-380-451 in 1 CARTON06/01/2010
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63868-380-902 in 1 CARTON06/01/2010
    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 FINALpart33406/01/2010
    Labeler - CDMA (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(63868-380)