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

  • NDC Code(s): 62011-0271-1, 62011-0271-2
  • Packager: Strategic Sourcing Services LLC
  • 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 January 20, 2022

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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
    • 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: 1-800-222-1222.

  • 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
  • Inactive ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions or comments?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson Corp., via Strategic
    Sourcing Services LLC, Memphis, TN 38141

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

    NDC 62011-0271-1

    Health Mart®

    Compare to Fleet® Enema
    Saline Active Ingredients*

    Complete &
    Ready-To-Use
    Enema
    Saline Laxative

    For Relief of
    Occassional
    Constipation

    Lubricated Tip
    Works In Minutes
    Not Made With
    Natural Rubber
    Latex

    4.5 Fl oz (133 mL)
    Single Pack

    PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HEALTHMART SALINE SINGLE   LAXATIVE
    sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0271
    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:62011-0271-11 in 1 CARTON03/20/2012
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62011-0271-22 in 1 CARTON03/20/2012
    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 FINALpart33403/20/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex, LLC062808196MANUFACTURE(62011-0271)
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