ENEMEEZ- docusate sodium liquid

ENEMEEZ by

Drug Labeling and Warnings

ENEMEEZ 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 delivered dose)

Docusate Sodium USP 283 mg

Purpose

Stool Softener Laxative

Uses

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

Warnings

For rectal use only. Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Do not use

• Laxative products when abdominal pain, nausea or vomiting are present.
• Laxative products for a period longer than 1 week unless directed by a doctor.

Stop use and ask a doctor if you have:

• Rectal bleeding.
• Noticed a sudden change in bowel habits that persists over a period of 2 weeks
• Failed to have a bowel movement after use. This may indicate a serious condition.

PREGNANCY OR BREAST FEEDING

Pregnant or Lactating Women, ask a healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

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 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 left side with knees bent. Insert slowly into rectum, up to the shoulder of tube.

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. 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

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Questions or Comments:

(888) 273-9734 or www.enemeez.com

Manufactured by:

Summit Pharmaceuticals, Inc.

Phoenix, AZ 85027

Distributed by:

Alliance Labs, LLC.

Phoenix, AZ 85027

PRINCIPAL DISPLAY PANEL

Principal Display Panel:

Drug Facts:

INGREDIENTS AND APPEARANCE

ENEMEEZ 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17433-9876
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

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: 17433-9876-3	30 in 1 BOTTLE	06/15/2012
1	NDC: 17433-9876-0	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(17433-9876)