DOCUSATE SODIUM

SPIRIT PHARMACEUTICALS,LLC

Docusate Sodium capsules USP 100mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each capsule)
• Purpose
• DOCUSATE SODIUM Uses
• Warnings
• Directions
• Inactive ingredients
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each capsule)

Docusate sodium 100 mg

Purpose

Stool softener

DOCUSATE SODIUM 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.

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)

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