Label: REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE- sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form 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 29, 2022

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  • Drug Facts

    Drug Facts

  • Active ingredients & Purpose

    Active ingredients (in each 59 ml delivered dose)Purpose
    Dibasic Sodium Phosphate 3.5g.....Saline laxative
    Monobasic Sodium Phosphate 9.5g.....Saline laxative
  • Uses

    • 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 the child

    • has already used a laxative for more than 3 days
    • has kidney disease, have heart problems, or are dehydrated
    • is on a sodium-restricted diet
    • has abdominal pain, nausea, or vomiting
    • has a sudden change in bowel habits lasting more than 2 weeks

    Ask a doctor or pharmacist before use if

    the child is 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, dizziness, 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 under 12 years of ageUse 1 bottle once daily
    children under 2 years of ageDO NOT USE
  • Other information

    • each 59 mL contains 2.2g 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?

    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

    NDC 69626-0085-7

    RELIEF ™
    SALINE LAXATIVE

    Pediatric
    Ready-to-Use

    ENEMA

    For relief of occasional constipation

    • Pre-Mixed
    • Not Made With Natural Rubber Latex

    Ages 2-11

    Lubricated Tip
    2.25 FL OZ (67 mL)

    PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE 
    sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69626-0085
    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:69626-0085-71 in 1 CARTON10/01/2019
    167 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2019
    Labeler - Leosons International (148605470)
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