DOCUSOL PLUS- docusate sodium w/benzocaine liquid

DocuSol Plus by

Drug Labeling and Warnings

DocuSol 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 Ingredients (per delivered dose)

Benzocaine 20 mg

Docusate Sodium USP 283 mg

Purpose

(Benzocaine).............. Anesthetic

(Docusate Sodium).... 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. Individuals with sensitivity to Benzocaine should not use this product. 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 health 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 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

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSOL PLUS 
docusate sodium w/benzocaine liquid

Product 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
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

Labeler - Enemeez Inc. DBA Summit Pharmaceuticals (010717819)

Establishment
Name	Address	ID/FEI	Business Operations
Enemeez Inc. DBA Summit Pharmaceuticals		010717819	manufacture(17433-9883)