ENEMEEZ PLUS- docusate sodium and benzocaine liquid

ENEMEEZ Plus by

Drug Labeling and Warnings

ENEMEEZ Plus by is a Otc medication manufactured, distributed, or labeled by Enemeez LLC DBA Summit Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ENEMEEZ PLUS 
docusate sodium and benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17433-9877
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: 17433-9877-3	30 in 1 BOTTLE	06/15/2012
1	NDC: 17433-9877-0	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	06/15/2012

Labeler - Enemeez Inc. DBA Summit Pharmaceuticals (010717819)

Registrant - Enemeez Inc. DBA Summit Pharmaceuticals (010717819)

Establishment
Name	Address	ID/FEI	Business Operations
Enemeez Inc. DBA Summit Pharmaceuticals		010717819	manufacture(17433-9877)