DOCUSATE SODIUM - docusate sodium capsule, liquid filled
A-S Medication Solutions

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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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

if you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

stomach pain, nausea or vomiting
have 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
you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding,

ask a health 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

doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over	take 1 to 3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

each capsule contains sodium 6 mg
store at room temperature 15o-30oC (59o-86oF)
Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special

Questions?

Adverse drug event call (800) 687-0176

HOW SUPPLIED

Product: 50090-0358

Docusate Sodium

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-0358(NDC:66424-030)
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Two toned- white and clear red)	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	51A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50090-0358-0	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014	10/31/2018
2	NDC:50090-0358-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014	10/31/2018
3	NDC:50090-0358-2	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014	10/31/2018
4	NDC:50090-0358-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/28/2014	10/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/15/2010	10/31/2018

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-0358) , REPACK(50090-0358)

Revised: 5/2021

Document Id: a6f2ce2f-bea6-4ebd-9de7-ecfe4727d830

Set id: cf6b779c-a9d5-4416-a217-36f19758af55

Version: 8

Effective Time: 20210505

A-S Medication Solutions