DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC, SOFTGEL HEALTHCARE PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

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 presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• 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

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

• Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years and over: take 1-3 capsules daily
• children 2 to under 12 years of age: take 1 capsule daily
• children under 2 years: ask a doctor

Inactive ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, PEG 400, propylene glycol, propylparaben, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL

Docusate Sodium capsules USP 100mg

Each Softgel Contains:
(Docusate Sodium USP 100mg)

LOT NO	:			QUANTITY	:
DRUM NO	:			NDC NO	: 68210-0401-*
MFG DATE	:			EXP DATE	:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE             : 35916
LIC NO.                              : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

• 1 - 10
• 2 - 30
• 3 - 100
• 4 - 1000
• 5 - 16000
• 6 - 20000

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0401
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C RED No. 33 (UNII: 9DBA0SBB0L)
FD&C RED No. 40 (UNII: WZB9127XOA)
FD&C Yellow No. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	DO4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0401-1	10 in 1 BOX
2	NDC: 68210-0401-2	30 in 1 BOX
3	NDC: 68210-0401-3	100 in 1 BOX
4	NDC: 68210-0401-4	1000 in 1 BOX
5	NDC: 68210-0401-5	16000 in 1 BOX
6	NDC: 68210-0401-6	20000 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/01/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PVT LTD		675584180	MANUFACTURE