Docusate Sodium Capsules Usp 100mg

Docusate Sodium Capsules Usp 100mg
SPL v1
SPL
SPL Set ID 84ee7230-0bf6-4107-b5fa-d6fa265139d0
Route
ORAL
Published
Effective Date 2010-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Polyethylene Glycol 400 Glycerin Gelatin Sorbitol Water D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: DO4 Shape: oval Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-03-01
Description

Drug Facts

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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
Section 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 53414-9

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

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
Active Ingredient (in Each Capsule)

Docusate sodium 100 mg

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Section 50570-1 (50570-1)

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor
Section 53414-9 (53414-9)

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

Purpose

Stool softener

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 (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 (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
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Docusate sodium 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:00.930397 · Updated: 2026-03-14T22:52:19.062647