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NDC 17433-9991-05 CVS Adult Enema 20; 283 mg/4.6g; mg/4.6g Details

CVS Adult Enema 20; 283 mg/4.6g; mg/4.6g

CVS Adult Enema is a RECTAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Summit Pharmaceuticals. The primary component is BENZOCAINE; DOCUSATE SODIUM.

Product Information

NDC	17433-9991
Product ID	17433-9991_ca0130ce-6240-60ff-e053-2995a90aa683
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Adult Enema
Proprietary Name Suffix	n/a
Non-Proprietary Name	docusate sodium w/benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	RECTAL
Active Ingredient Strength	20; 283
Active Ingredient Units	mg/4.6g; mg/4.6g
Substance Name	BENZOCAINE; DOCUSATE SODIUM
Labeler Name	Summit Pharmaceuticals
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 17433-9991-05 (17433999105)

Pricing Information	N/A
NDC Package Code	17433-9991-5
Billing NDC	17433999105
Package	5 TUBE in 1 BOX (17433-9991-5) / 4.6 g in 1 TUBE (17433-9991-1)
Marketing Start Date	2014-09-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 061acc74-eb3e-6887-e054-00144ff8d46c Details

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

SPL UNCLASSIFIED SECTION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

CVS.com ®

1-800-SHOP CVS

V-31560

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ADULT ENEMA

docusate sodium w/benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17433-9991
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	283 mg in 4.6 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 mg in 4.6 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:17433-9991-5	5 in 1 BOX	09/01/2014	06/30/2024
1	NDC:17433-9991-1	4.6 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/2014	06/30/2024

Labeler - Summit Pharmaceuticals (010717819)

Revised: 8/2021

Document Id: ca0130ce-6240-60ff-e053-2995a90aa683

Set id: 061acc74-eb3e-6887-e054-00144ff8d46c

Version: 11

Effective Time: 20210820