Label: CVS PHARMACY- saline laxative enema

  • 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 December 21, 2017

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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

    For rectal use only.

    Dosage warning

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

    Ask a doctor or pharmacist before using if the child

    • 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 the child

    • has rectal bleeding
    • has no bowel movement within 30 minutes of enema use
    • has symptoms of dehydration (thirstiness, dizzyness, 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 11 years1 bottle once daily
    children under 2 yearsask a doctor
  • 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?

    866-323-0107 or www.natureplex.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton

    CVS
    Health™

    Compare to the active
    ingredients in Fleet®
    Pedia-Lax Enema*

    NDC 59779-969-40

    Children's

    Ready-to-Use

    Enema

    SALINE LAXATIVE

    • Pre-mixed
    • For relief of occasional
      constipation
    • Lubricated tip

    AGES
    2-11

    2.25 FL OZ (66 mL)

    PRINCIPAL DISPLAY PANEL - 66 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY 
    saline laxative enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-969
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM3.5 g  in 59 mL
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM9.5 g  in 59 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:59779-969-401 in 1 CARTON05/20/2014
    159 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 finalpart33405/20/2014
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(59779-969)
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