Label: CVS ADULT ENEMA- docusate sodium w/benzocaine liquid

  • NDC Code(s): 17433-9991-1, 17433-9991-5
  • Packager: Summit Pharmaceuticals
  • 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 August 20, 2021

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

  • Drug Facts

    Active Ingredients (in each delivered dose)

    Benzocaine 20 mg

    Docusate Sodium USP 283 mg

    Purpose

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

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

  • Uses

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

    For rectal use only

    Do not use

    • If individual is sensitive to Benzocaine.
    • If you are presently taking mineral oil, unless directed by a doctor.
    • When abdomen pain, nausea or vomiting are present.
    • For a period longer than 1 week unless directed by a doctor.

    Stop use and ask a doctor if

    • Symptoms last more than 2 weeks.
    • You have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition.

    Pregnant or lactating women, ask a health professional before use.

    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 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. 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. Insert up to the shoulder of tube. 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

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

  • Inactive Ingredients

    Glycerine USP and Polyethylene Glycol

  • QUESTIONS

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    ©2016 CVS/pharmacy

    CVS.com ®

    1-800-SHOP CVS

    V-31560

  • PRINCIPAL DISPLAY PANEL

    5-Count Carton

  • INGREDIENTS AND APPEARANCE
    CVS ADULT ENEMA 
    docusate sodium w/benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17433-9991
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM283 mg  in 4.6 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mg  in 4.6 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17433-9991-55 in 1 BOX09/01/201406/30/2024
    1NDC:17433-9991-14.6 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/201406/30/2024
    Labeler - Summit Pharmaceuticals (010717819)