Label: SALINE ENEMA- sodium phosphate monobasic, sodium phosphate dibasic enema

  • NDC Code(s): 67777-402-01, 67777-402-02
  • Packager: Dynarex Corporation
  • 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 November 29, 2022

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  • Active Ingredients

    ( in each 118 mL delivered dose)

    Dibasic Sodium Phosphate 7g

    Monobasic Sodium Phosphate 19g

  • Purpose

    Saline Laxative

  • Uses

    • For relief of occasional constipation

    • This product generally produces bowel movement in 2 to 15 minutes

  • Warnings:

    For rectal use only

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

    Do not use

    • Laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

    • Longer than 1 week unless directed by a doctor

    • This product if you are on a low salt diet unless directed by a doctor

    • This product if you have kidney disease unless directed by a doctor

    Ask a doctor before use if you have:

    Noticed a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if:

    • If you have rectal bleeding or fail to have a bowel movement after use

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years old and over - 1 bottle once daily

    Children 2 to under 12 years of age - 1/2 bottle once daily, discard unused portion

    Children under 2 years - Consult a physician.

  • Other information:

    • Sodium content in each dose (1 bottle): 4.4 g
    • Store at room temperature 15º-30ºC (59º- 8ºF)
  • Inactive ingredients

    Benzalkonium Chloride, Disodium EDTA, Purified Water

  • Questions?

    1-888-DYNAREX Monday - Friday 9AM - 5PM EST

  • Label

    4719 IN MASTER4719 Enema Saline Laxative

  • INGREDIENTS AND APPEARANCE
    SALINE ENEMA 
    sodium phosphate monobasic, sodium phosphate dibasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-402
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC7 g  in 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-402-0248 in 1 CASE08/29/2012
    1NDC:67777-402-011 in 1 BOX
    1118 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 finalpart33408/29/2012
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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