DOCUSATE SODIUM- docusate sodium tablet, film coated
Medline Industries, Inc.

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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Medline 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

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of Reach of Children.

In case of oversode, 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.

*This product is not manufactured or distributed by Purdue Products, L.P., owner of the registered trademark Colace®

Distributed By: Medline Industries, INc.

One Medline Place, Mundelein,IL

60060 USA www.medline.com

NDC 53329-660-30

*Compare to the Active Ingredient in Colace ®

DOCUSATE SODIUM

STOOL SOFTENER

Relieves Occasional Constipation (Irregularity)

100 mg

100 Tablets - 100 mg each

Label

DOCUSATE SODIUM
docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-660
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

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:53329-660-30	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2013	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/16/2013	01/31/2019

Labeler - Medline Industries, Inc. (025460908)

Revised: 12/2019

Document Id: 995b21a2-ae38-a8af-e053-2a95a90a151c

Set id: 2bfdfbbd-dc5c-3dc0-e054-00144ff88e88

Version: 4

Effective Time: 20191210

Medline Industries, Inc.