DOCUSATE SODIUM- docusate sodium capsule
St. Marys Medical Park Pharmacy

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

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose

Warnings

Do not use

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Ask a doctor before use if you

are taking mineral oil
have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have no bowel movement after 3 days
you have rectal bleeding

These could be signs of a serious condition

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

do not exceed recommended dose

adults and children over 12 years	take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years	take 1 softgel daily
children under 6 years	consult a doctor

Other information

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature 15 o to 30 oC (59 o to 86 oF)
protect from moisture

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.

Questions?

Adverse drug event call: (866) 562-2756

Docusate Sodium
St Marys Pharmacy

Docusate Sodium Label

DOCUSATE SODIUM
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-384(NDC:16103-384)
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

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:60760-384-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016	12/06/2017
2	NDC:60760-384-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016	10/31/2018
3	NDC:60760-384-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2016	12/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	04/01/2016	10/31/2018

Labeler - St. Marys Medical Park Pharmacy (063050751)

Name	Address	ID/FEI	Business Operations
Establishment
St Marys Medical Park Pharmacy		063050751	relabel(60760-384) , repack(60760-384)

Revised: 10/2018

Document Id: 77e4a56d-471d-49d8-e053-2991aa0a06ec

Set id: 32307aff-40d3-686c-e054-00144ff8d46c

Version: 3

Effective Time: 20181010

St. Marys Medical Park Pharmacy