Label: ENEMEEZ PLUS- docusate sodium and benzocaine liquid

  • NDC Code(s): 17433-9877-0, 17433-9877-2, 17433-9877-3, 17433-9877-5, view more
    17433-9877-6, 17433-9877-7
  • Packager: Enemeez LLC DBA Summit Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (per mini enema)

    Docusate Sodium USP 283 mg

    Benzocaine 20mg

  • PURPOSE

    Docusate Sodium USP 283 mg ............. Stool Softener Laxative

    Benzocaine 20mg ................................ Anesthetic

  • Uses

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

  • Warnings

    For rectal use only. This is not a suppository. Do not take orally. Individuals with sensitivity to Benzocaine should not use this product.

  • Ask a doctor before use if you have:

    • abdominal pain, nausea or vomiting.
    • a sudden change in bowel habits that persists over a period of 2 weeks.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are presently taking mineral oil.

  • Stop use and ask a doctor if you:

    • have rectal bleeding.
    • failed to have a bowel movement after use. This may indicate a serious condition.
    • encounter resistance. Forcing the tube may result in injury or damage to the rectum. If product is not administered properly and occasional rectal examinations are not performed, serious complications can arise. Occasional rectal exams are imperative for patients with impaired rectal function, especially loss of sensation.
    • require a bowel program for longer than 1 week.
    • experience rectal irritation or a rash around the anus appears.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of accidental ingestion or overdose, 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 2 years and over but not more than 12 years should consult a doctor prior to use and not exceed one unit daily (with adult supervision).

    Twist off and remove tip; Lubricate tip prior to insertion: Place a few drops of water or product on the shaft prior to insertion. Also apply one of these lubricants to the anus before inserting the enema. With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Continue squeezing the tube until it is removed from the rectum. Remove the disposable tube and discard. A small amount of liquid may remain in the tube after use.

    Positioning:
    For best results, lay on the left side with knees bent.

    Alternate Positions:

    • Administer while seated on the toilet.
    • Kneel with the left arm folded comfortably, then lower head and chest forward until side of face is resting on the surface.
  • Other Information

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

  • Inactive Ingredients

    Inactive Ingredients Polyethylene Glycol and Glycerin USP

  • QUESTIONS

    Questions or Comments: 1-888-273-9734 or www.enemeez.com

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Enemeez, Inc., Phoenix, AZ 85050

    Distributed by:
    Alliance Labs, L.L.C
    2515 E. Rose Garden Lane, Suite #1
    Phoenix, AZ 85050

  • PRINCIPAL DISPLAY PANEL

    9877-5

    30count

  • INGREDIENTS AND APPEARANCE
    ENEMEEZ PLUS 
    docusate sodium and benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9877
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM283 mg  in 5 mL
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 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:17433-9877-330 in 1 CONTAINER06/15/2012
    1NDC:17433-9877-05 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:17433-9877-635 in 1 CONTAINER10/08/2021
    2NDC:17433-9877-05 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:17433-9877-55 in 1 CONTAINER01/14/2022
    3NDC:17433-9877-05 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:17433-9877-76 in 1 CONTAINER09/14/202302/23/2024
    4NDC:17433-9877-05 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:17433-9877-22 in 1 CONTAINER01/26/2024
    5NDC:17433-9877-05 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(17433-9877)