DOCUSATE SODIUM CAPSULES USP 50 MG

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient(in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

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

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 1-6 capsules daily
children 2 to under 12 years of age	take 1-3 capsules daily
children under 2 years	ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

OTC - QUESTIONS SECTION

Questions? 1-888-726-7535
(8am-5pm, EST, Mon.-Fri.).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)

LOT NO :

DRUM NO :

MFG DATE :

QUANTITY :

NDC NO : 68210-0402-

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

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

• DOCUSATE SODIUM
• DOCUSATE
• POLYETHYLENE GLYCOL 400
• GLYCERIN
• GELATIN
• SORBITOL
• WATER
• PROPYLENE GLYCOL
• D&C RED NO. 33

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 5 · 294 matching rows.

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Matched openFDA labels page 1 of 1 · 1 matching rows.

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Adverse event summaries are temporarily unavailable. Other product information remains available.