SPL v4
SPL
SPL Set ID b10fdf50-289e-41f3-9b83-a4e4dd892f88
Route
ORAL
Published
Effective Date 2019-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15
Description

Drug Facts

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product 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 50568-5

Ask a doctor or pharmacist before use if you arepresently taking mineral oil

Section 50569-3

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • a sudden change in bowel habits that lasts more than 2 weeks
Section 53414-9

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

Directions

take with a glass of water

Adults and children 12 years and over

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

Children 2 to under 12 years of age

1 softgel daily

children under 2 years of age

ask a doctor

Other Information
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity
Inactive Ingredients

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 no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a 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 : 15000 Capsules

NDC. No : 53345-008-02

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.

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Structured Label Content

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product 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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently taking mineral oil

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain, nausea or vomitting
  • a sudden change in bowel habits that lasts more than 2 weeks
Section 53414-9 (53414-9)

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

Purpose

Stool softener

Directions

take with a glass of water

Adults and children 12 years and over

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

Children 2 to under 12 years of age

1 softgel daily

children under 2 years of age

ask a doctor

Other Information (Other information)
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

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 no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a 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 : 15000 Capsules

NDC. No : 53345-008-02

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.

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.793514 · Updated: 2026-03-14T23:05:18.894850