DOCUSATE SODIUM - docusate sodium capsule
Bryant Ranch Prepack

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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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

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 100mg Capsule

DOCUSATE SODIUM
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-1360(NDC:16103-384)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Docusate Sodium (Docusate)	Docusate Sodium	100 mg

Inactive Ingredients
Ingredient Name	Strength
D&C Yellow No. 10
FD&C Red No. 40
Gelatin
Glycerin
Polyethylene Glycol
Propylene Glycol
Sorbitol

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:63629-1360-5	90 CAPSULE ( CAPSULE) in 1 BOTTLE	None
2	NDC:63629-1360-9	56 CAPSULE ( CAPSULE) in 1 BOTTLE	None
3	NDC:63629-1360-7	10 CAPSULE ( CAPSULE) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/22/2007

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Accucaps Industries Ltd.		248441727	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK, RELABEL

Revised: 01/2007 Bryant Ranch Prepack