Label: DOCUSOL PLUS- docusate sodium w/benzocaine liquid
- NDC Code(s): 17433-9883-1, 17433-9883-5
- Packager: Enemeez LLC DBA 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 November 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if you have:
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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 the 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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOCUSOL PLUS
docusate sodium w/benzocaine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17433-9883 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 283 mg in 5 mL BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17433-9883-5 5 in 1 BOX 07/12/2013 10/31/2024 1 NDC:17433-9883-1 5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 07/12/2013 10/31/2024 Labeler - Enemeez LLC DBA Summit Pharmaceuticals (010717819) Establishment Name Address ID/FEI Business Operations Enemeez LLC DBA Summit Pharmaceuticals 010717819 manufacture(17433-9883)
