SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [FAMILY DOLLAR STORES, INC.]

SALINE LAXATIVE (SODIUM PHOSPHATE) ENEMA [FAMILY DOLLAR STORES, INC.]
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NDC 55319-005-35
Set ID 7f4146e6-1737-43b4-adf9-c632d1942266
Category HUMAN OTC DRUG LABEL
Packager FAMILY DOLLAR STORES, INC.
Generic Name
Product Class
Product Number
Application Number PART334
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 118 mL 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
    • 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 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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC
    10611 MONROE RD., MATTHEWS, NC 28105

  • PRINCIPAL DISPLAY PANEL - 2 Bottle Carton

    COMPARE TO FLEET®
    ACTIVE INGREDIENTS*

    FAMILY
    wellness™

    laxative

    READY-TO-USE

    SALINE
    enema

    Not made with natural
    rubber latex

    For relief of occasional
    constipation

    OTC
    network

    100% SATISFACTION
    GUARANTEED
    OR YOUR MONEY BACK

    NDC 55319-005-35

    2
    Bottles
    4.5 Fl Oz (133 mL) each

    PRINCIPAL DISPLAY PANEL - 2 Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SALINE LAXATIVE 
    sodium phosphate enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-005
    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:55319-005-352 in 1 BOX08/31/2012
    1133 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/31/2012
    Labeler - FAMILY DOLLAR STORES, INC. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATUREPLEX LLC062808196MANUFACTURE(55319-005)

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