SPL v5
SPL
SPL Set ID 85c64624-428d-46fa-8071-f42b8feec049
Route
ORAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: PC18 Shape: capsule Color: red Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-12-23
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 and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Do Not Use
  • if you are presently 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

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water 

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 use of 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 Softgel)

Docusate Sodium 100 mg

Principal Display Panel Shipping Label

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules

NDC. No : 53345-018-01

IMPORTANT:

1.Inspect immediately upon receipt.

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

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

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules

NDC. No : 53345-018-02

IMPORTANT:

1.Inspect immediately 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 REPACKAGING

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 and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Do Not Use (Do not use)
  • if you are presently 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)

Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water 

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 use of 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 Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg

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

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 20000 Capsules

NDC. No : 53345-018-01

IMPORTANT:

1.Inspect immediately upon receipt.

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

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

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules

NDC. No : 53345-018-02

IMPORTANT:

1.Inspect immediately 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 REPACKAGING

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.010195 · Updated: 2026-03-14T23:05:15.511736