Label: RELIEF- sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate 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 18, 2020

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  • Drug Facts

    Drug Facts

  • Active ingredients & Purpose

    Active ingredients (in each 118 mL delivered dose) Purpose
    Monobasic Sodium Phosphate 19 g...............................................Saline laxative
    Dibasic Sodium Phosphate 7 g.......................................................Saline laxative
  • Use

    for relief of occasional constipation

  • Warnings

    For rectal use only

    Dosage Warning:

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

    Ask a doctor before using this product if you

    • are on a sodium-restricted diet
    • have kidney disease
    • are 65 or older and under a doctor's care for any medical condition

    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

    Stop use and ask a doctor if you have

    • rectal bleeding
    • no bowel movement within 30 minutes of enema use
    • symptoms of dehydration (feeling thirsty, 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.
    • Do not use more unless directed by a doctor. See Warnings.
    • Do not use if taking another sodium phosphates product.
    Adults and Children 12 years and over1 Bottle
    Children 2 to under 12 years1/2 Bottle once daily
    Children under 2 yearsDO NOT USE
  • Other information

    • each 118 mL delivered dose contains: sodium 4.4 g
    • additional liquids by mouth are recommended while using this product
    • this product generally produces a bowel movement in 1-5 minutes
    • store between 15°- 30°C (59°- 86°F)
    • carton sealed for safety. Do not use if top or bottom flap of carton is torn or missing.
    • consult PHYSICIANS' DESK REFERENCE® for complete professional labeling.
  • Inactive ingredients

    Benzalkonium chloride, disodium EDTA, purified water

  • Questions?

    Call toll-free at +1-855-452-9500 or email info@Leosonsintl.com

  • Distributed by:


    Leosons

    10 Maryland Avenue

    Albany, New York 12205

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    RELIEF™

    SALINE LAXATIVE

    Ready-to-Use
    ENEMA

    For relief of
    occasional
    constipation

    • Pre-Mixed
    • Latex Free

    Lubricated Tip
    1 Bottle 4.5 FL OZ (133mL)

    Principal Display Panel - 133 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    RELIEF 
    sodium phosphate, monobasic and sodium phosphate, dibasic, heptahydrate enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0084
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 133 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:69626-0084-61 in 1 CARTON02/09/2015
    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 finalpart33402/09/2015
    Labeler - Leosons Overseas Corp (148605470)
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