Label: QUALITY CHOICE LAXATIVE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema

  • NDC Code(s): 83324-292-45, 83324-293-90
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

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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

    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 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 sodium 4.3 g
    • 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 CDMA, Inc.
    Novi, MI 48375

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 1 Bottle

    NDC# 83324-292-45

    QC®
    QUALITY
    CHOICE

    * Compare to the
    Active Ingredients
    in FLEET ® Enema

    Enema

    Laxative

    Complete, Ready-to-Use

    SODIUM PHOSPHATES
    RECTAL SOLUTION

    Not Made
    with Natural
    Rubber Latex

    Comfortable,
    Lubricated Tip

    Works In
    Minutes

    1
    Bottle
    4.5 Fl Oz (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 1 Bottle
  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 2 Bottles

    TWIN PACK

    QC®
    QUALITY
    CHOICE

    NDC# 83324-293-90

    * Compare to the
    Active Ingredients
    in FLEET ® Enema

    Enema

    Laxative

    Complete, Ready-to-Use

    SODIUM PHOSPHATES
    RECTAL SOLUTION

    Not Made with
    Natural Rubber Latex

    Comfortable,
    Lubricated Tip

    Works In
    Minutes

    2
    Bottles
    4.5 Fl Oz (133 mL) Each

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton - 2 Bottles
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE   LAXATIVE
    sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-292
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-292-451 in 1 CARTON06/01/2010
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00706/01/2010
    QUALITY CHOICE   LAXATIVE
    sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-293
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-293-902 in 1 CARTON06/01/2010
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00706/01/2010
    Labeler - Chain Drug Marketing Association (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(83324-292, 83324-293)
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