DOCUSATE SODIUM - docusate sodium capsule, liquid filled
Cypress Pharmaceuticals, 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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DOCUSATE SODIUM, USP 100 mg

Drug Facts

Active ingredient (in each softgel)
Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

For the relief of occasional constipation.
This product generally produces a bowel movement with in 12 to 72 hours.
Helps to prevent dry, hard stools.

WARNINGS

Do not use:

If you are currently taking mineral oil, unless directed by a doctor.
When abdominal pain, nausea or vomiting are present.
For longer than one week unless directed by a doctor.

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.

If pregnant or breast-feeding, ask a health care professional 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 over 12 years of age	Take only 1 to 2 softgels preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children 6 to 12 years of age	Take only 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under6 years of age	Do not use this product for children under 6 years of age unless directed by a doctor.

Other information

Each softgel contains 5 mg of Sodium.
Store at room temperature between 15°C to 30°C (59° to 86°F).
Do not use if safety seal under cap is broken or missing.
Keep lid tightly close.

Inactive Ingredients FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Purified Water, Sorbitol.

Questions? Call weekdays from 8 am to 5 pm (CST) at 1-800-856-4393. Serious side effects associated with use of this product may be reported to this number.

Distributed by:
Cypress Pharmaceuticals, Inc.
Madison, MS 39110

L373
Rev 096/10

Principal Display Panel

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60258-955
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60258-955-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2000	10/05/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	08/01/2000	10/05/2015

Labeler - Cypress Pharmaceuticals, Inc. (790248942)

Revised: 11/2017

Document Id: 1fa774a7-aa61-4a31-8251-642a38a40115

Set id: e0759ea6-f243-42e8-ae7e-9dcf1c254d57

Version: 2

Effective Time: 20171130

Cypress Pharmaceuticals, Inc.