DOCUSOL KIDS- docusate sodium liquid

DocuSol Kids by

Drug Labeling and Warnings

DocuSol Kids 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 100 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.

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

Children 2 years to under 12 years of age (with adult supervision) one unit daily. Children under 2 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 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 KIDS 
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17433-9884
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 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: 17433-9884-5	5 in 1 BOX	01/14/2014
1	NDC: 17433-9884-1	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	01/14/2014

Labeler - Enemeez Inc. DBA Summit Pharmaceuticals (010717819)

Establishment
Name	Address	ID/FEI	Business Operations
Enemeez Inc. DBA Summit Pharmaceuticals		010717819	manufacture(17433-9884)