Docusate Sodium 100mg Two-tone, Capsule, Liquid Filled

Docusate Sodium 100mg Two-tone, Capsule, Liquid Filled
SPL v3
SPL
SPL Set ID a923e5ca-86fd-4bf9-9931-180ddfdeae66
Route
ORAL
Published
Effective Date 2019-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Propylene Glycol Water Sorbitol Anhydrous Citric Acid Fd&c Red No. 40 D&c Red No. 33 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 657 Shape: capsule Color: red Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-08-11
Description

Drug Facts

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a 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 50569-3

Ask a doctor before use if you have

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

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 of ages and over

take 1 to 3 softgels daily

Children 2 and under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor
Do Not Use
  • if you are currently taking mineral oil, unless told to do so by a doctor 

Other Information
  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei 430206,

China

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
Active Ingredient (in Each Capsule)

Docusate Sodium 100 mg

Principal Display Panel Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules

NDC. No : 53345-023-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a 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 50569-3 (50569-3)

Ask a doctor before use if you have

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

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 of ages and over

take 1 to 3 softgels daily

Children 2 and under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor
Do Not Use (Do not use)
  • if you are currently taking mineral oil, unless told to do so by a doctor 

Other Information (Other information)
  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients (Inactive ingredients)

D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei 430206,

China

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after using a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Docusate Sodium 100 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules

NDC. No : 53345-023-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:33.096101 · Updated: 2026-03-14T23:05:22.628914