DOCUSATE SODIUM - docusate sodium tablet, film coated
Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Docusate Sodium 100mg

Purpose

Stool Softener

Uses

for relief of occasional constipation (irregularity).This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

laxative products for longer than one week unless directed to do so by a doctor
if you are presently taking mineral oil unless told to do so by a doctor

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use these could be signs of a serious condition.

If pregnant or breast-feeding

ask a doctor before use

Keep out of reach of Children

In case of overdose, get medical help or contact a poison control center right away.

Directions

Adults and children 12 years of age and older:	Take 1 tablet as needed, not to exceed more than 3 tablets daily, or as directed by a doctor
Children under 12 years of age	Consult a doctor before use.

Other information

Each tablet contains Calcium 40 mg
Each tablet contains Sodium 10 mg
Store at room temperature
Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Pregelatinized Starch, Silica, Sodium Benzoate, Stearic acid.

Questions?

If you have any questions or comments or to report an adverse event please contact 1-800-medline

Principal Display Panel

ONDRA Pharmaceuticals
Docusate Sodium 100mg
Stool Softener
Relieves Occasional (Irregularity)
compare to active ingredient in COLACE®
This product is not manufactured or distributed by Purdue Products,LP.,owner of the registerd trademark Colace®
100 Tablets 100mg Each

DOCUSATE SODIUM
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51645-606
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STARCH, CORN
SILICON DIOXIDE
SODIUM BENZOATE
STEARIC ACID

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (Round Biconvex)	Size	11mm
Flavor		Imprint Code	GPI;S1
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51645-606-01	100 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/30/2012

Labeler - Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals (055942270)

Revised: 03/2012 Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals