DOSS Sodium 100 MG Oral Capsule

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Drug Information

Imprint:	51A
Shape:	C48345
Color:	C48326
Ingredients:	Docusate
Size:	5.00
Score:	1
Rxtty:	SY
Author:	Unit Dose Services
Inactive Ingredients:	D&C RED NO. 33 / FD&C RED NO. 40 / FD&C YELLOW NO. 6 / GELATIN / GLYCERIN / POLYETHYLENE GLYCOLS / PROPYLENE GLYCOL / SORBITOL>

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

adults and children 12 years and over Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â	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:Â 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: 50436-1222

NDC: 50436-1222-1 30 CAPSULE, LIQUID FILLED in a BOTTLE
DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUMÂ
docusate sodium capsule, liquid filled

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100Â mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)	Â
FD&C RED NO. 40 (UNII: WZB9127XOA)	Â
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)	Â
GELATIN (UNII: 2G86QN327L)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)	Â
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	Â
SORBITOL (UNII: 506T60A25R)	Â

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50436-1222-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/15/2010

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

Labeler -Â Unit Dose Services (831995316)

Name	Address	ID/FEI	Business Operations
Establishment
Unit Dose Services		831995316	REPACK(50436-1222) , RELABEL(50436-1222)