Docusate Sodium by Direct Rx DOCUSATE SODIUM tablet

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Direct Rx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

OTC - PURPOSE SECTION

Stool softener

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

OTC - ASK DOCTOR SECTION

stomach pain  
nausea  
vomiting  
noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
you need to use a laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

each softgel contains: sodium 5 mg VERY LOW SODIUM  
store at 15°-30°C (59°-86°F)  
keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

SPL UNCLASSIFIED SECTION

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0 07/2011
015021CPR

WARNINGS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-888(NDC:0603-0150)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red (Reddish)	Score	no score
Shape	capsule	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-888-71	100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 61919-888-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
3	NDC: 61919-888-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2015

Labeler - Direct Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct Rx		079254320	relabel(61919-888) , repack(61919-888)