Label: ENEMEEZ- docusate sodium liquid

  • NDC Code(s): 17433-9876-0, 17433-9876-2, 17433-9876-3, 17433-9876-5, view more
    17433-9876-6, 17433-9876-9
  • Packager: Enemeez LLC DBA Summit Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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  • Drug Facts

    Active ingredient (per delivered dose)

    Docusate Sodium USP 283 mg

  • Purpose

    Stool Softener Laxative

  • Uses

    • For relief of occasional constipation (irregularity).
    • This product generally produces a bowel movement in 2 to 15 minutes.
  • Warnings

    For rectal use only. Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

  • Do not use

    • Laxative products when abdominal pain, nausea or vomiting are present.
    • Laxative products for a period longer than 1 week unless directed by a doctor.
  • Stop use and ask a doctor if you have:

    • Rectal bleeding.
    • Noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • Failed to have a bowel movement after use. This may indicate a serious condition.
  • PREGNANCY OR BREAST FEEDING

    Pregnant or Lactating Women, ask a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children under 12 years of age, consult a doctor prior to use.

    • Twist off and remove tip.
    • Lubricate tip prior to insertion:

    Place a few drops of the tube's liquid content on the shaft prior to insertion.

    Also apply liquid content or lubricant to the anus before inserting the mini-enema.

    • Positioning: For best results, lay on left side with knees bent. Insert slowly into rectum, up to the shoulder of tube.

    Alternate positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface.

    • With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.

  • Other Information

    Other Information Store at room temperature 15°-30° C (59°-86° F)

  • Inactive Ingredients

    Glycerin USP and Polyethylene Glycol

  • Questions or Comments:

    (888) 273-9734 or www.enemeez.com

    Manufactured by:

    Summit Pharmaceuticals, Inc.

    Phoenix, AZ 85027

    Distributed by:

    Alliance Labs, LLC.

    Phoenix, AZ 85027

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panels:

    9876-5

    30count

  • INGREDIENTS AND APPEARANCE
    ENEMEEZ 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9876
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM283 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17433-9876-330 in 1 CONTAINER06/15/2012
    1NDC:17433-9876-05 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:17433-9876-935 in 1 CONTAINER10/08/2021
    2NDC:17433-9876-05 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:17433-9876-55 in 1 CONTAINER01/14/2022
    3NDC:17433-9876-05 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:17433-9876-66 in 1 CONTAINER09/14/202302/23/2024
    4NDC:17433-9876-05 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:17433-9876-22 in 1 CONTAINER01/26/2024
    5NDC:17433-9876-05 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/15/2012
    Labeler - Enemeez LLC DBA Summit Pharmaceuticals (010717819)
    Registrant - Enemeez LLC DBA Summit Pharmaceuticals (010717819)
    Establishment
    NameAddressID/FEIBusiness Operations
    Enemeez LLC DBA Summit Pharmaceuticals010717819manufacture(17433-9876)
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