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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Ondra Docusate Sodium 100 mg Tablets

Active ingredient (in each tablet)

Docusate Sodium 100 mg

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 lasts 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 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 100 mg
Stool Softener
Relieves Occasional Constipation (Irregularity)
Compare to the Active Ingredient in Colace®
This product is not manufactured or distributed by Purdue Products, L.P.,owner of the registered trademark Colace®.
100 TABLETS 100 mg 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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51645-606-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2012	11/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/30/2012	11/30/2017

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

Name	Address	ID/FEI	Business Operations
Establishment
Gemini Pharmaceuticals, Inc.		055942270	manufacture(51645-606)

Revised: 11/2017

Document Id: 5df4c41e-c1b7-e1e1-e053-2a91aa0a1a69

Set id: f27cb4d9-07af-4c17-93f2-41dc4e46a4bb

Version: 8

Effective Time: 20171114

Gemini Pharmaceuticals, Inc. dba ONDRA Pharmaceuticals