Label: PRO-ENEMA SINGLE SALINE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema

  • NDC Code(s): 71451-001-01
  • Packager: Propharma Medical Supplies
  • 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 June 8, 2017

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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

  • Warnings

    Dosage warning

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

    For rectal use only.

    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:

  • Directions

    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 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

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    NDC 00000-000-00

    *Compare To Fleet®

    Ready-to-Use
    Pro-Enema
    Saline

    Latex
    Free

    For relief of
    occasional
    constipation

    1 Bottle
    4.5 Fl Oz (133 mL)

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PRO-ENEMA SINGLE SALINE   LAXATIVE
    sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71451-001
    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 Anhydrous (UNII: 8NLQ36F6MM)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71451-001-011 in 1 CARTON06/06/2017
    1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33406/06/2017
    Labeler - Propharma Medical Supplies (558460257)
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