SUNMARK SALINE SINGLE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [MCKESSON]

SUNMARK SALINE SINGLE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [MCKESSON]
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NDC 49348-186-14, 49348-186-20
Set ID 06720229-7d58-499e-b7de-cb4bda5ae416
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
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
    • 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?

    1-800-633-5463

  • SPL UNCLASSIFIED SECTION

    Distributed By Strategic Sourcing Services LLC
    6555 State Highway 161, Irving, TX 75039

  • PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

    sunmark®

    COMPARE TO
    FLEET® ENEMA SALINE
    ACTIVE INGREDIENTS*

    NDC 49348-186-20

    complete &
    ready-to-use
    enema
    Saline Laxative

    For relief of
    occasional constipation

    Soft, flexible
    Comfort tip

    Pre-mixed

    LATEX FREE

    4.5 FL OZ
    (133 ml)

    PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK SALINE SINGLE   LAXATIVE
    sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-186
    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 FORM7 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:49348-186-201 in 1 CARTON03/06/2013
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49348-186-142 in 1 CARTON03/06/2013
    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 FINALpart33403/06/2013
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(49348-186)