Docusate Sodium, USP Stool Softener

Drug Details [pdf]

DOCUSATE SODIUM- docusate sodium capsule, liquid filled
Safecor Health, LLC

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
Stool Softener

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

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

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 you are pregnant or breast-feeding,

ask a healthcare professional before use.

Directions

Adults and Children over 12 years of age	Take orally 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 orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 6 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°F to 86°F).
Do not use if seal on packaging is open or missing.

Rev: 317-00 08/2014

Inactive ingredients

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

Questions or Comments?

Call 1 (800) 447-1006

Package/Label Principal Display Panel

Docusate 100 mg Robot Unit Dose Box Label

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-317(NDC: 54629-600)
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	NV13
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 48433-317-10	100 in 1 BOX, UNIT-DOSE	09/30/2014	11/11/2019
1	NDC: 48433-317-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/30/2014	11/11/2019

Labeler - Safecor Health, LLC (828269675)

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		828269675	REPACK(48433-317)

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		078805287	REPACK(48433-317)

Revised: 11/2019

Document Id: 23c845f2-db35-4dfb-be16-25b7058f5318

Set id: 09447713-fdab-4cb7-90a2-f769693dde6f

Version: 2

Effective Time: 20191123

Safecor Health, LLC