Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin Citric Acid Monohydrate Sorbitan

Identifiers & Packaging

Pill Appearance

Imprint: PC1 Shape: capsule Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-01

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium USP, 100 mg

Uses

for relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours

Directions

take with a glass of water

adults and children 12 years and over	take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Do Not Use

if you are presently taking mineral oil, unless directed a doctor.

Product Label

TOPCARE HEALTH Stool Softener

Other Information

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® STOOL SOFTENER†

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

Comfortable relief of painful, hard, dry stools
Stimulant-free
Relief of occasional constipation

SOFTGELS

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

TOPCO ASSICIATES LLC

ITASCA, IL 60143

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition.
you need to use a stool softener laxative for more than 1 week

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate Sodium USP, 100 mg

Structured Label Content

Uses

for relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener laxative

Directions

take with a glass of water

adults and children 12 years and over	take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses
children 2 to under 12 years of age	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 directed a doctor.

Product Label

TOPCARE HEALTH Stool Softener

Other Information (Other information)

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Principal Display Panel (Principal display panel)

COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® STOOL SOFTENER†

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

Comfortable relief of painful, hard, dry stools
Stimulant-free
Relief of occasional constipation

SOFTGELS

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

TOPCO ASSICIATES LLC

ITASCA, IL 60143

Ask A Doctor Before Use If (Ask a doctor before use if)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition.
you need to use a stool softener laxative for more than 1 week

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium USP, 100 mg

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener laxative", "Directions": "take with a glass of water adults and children 12 years and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor", "Do not use": "if you are presently taking mineral oil, unless directed a doctor.", "Product Label": "TOPCARE HEALTH Stool Softener", "Other information": "each softgel contains: sodium 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)", "Inactive ingredients": "citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink", "Questions or comments?": " Call toll free 1-888-423-0139 ", "Principal display panel": "COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® STOOL SOFTENER† Stool Softener DOCUSATE SODIUM 100 mg STOOL SOFTENER LAXATIVE Comfortable relief of painful, hard, dry stools Stimulant-free Relief of occasional constipation SOFTGELS †This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: TOPCO ASSICIATES LLC ITASCA, IL 60143", "Ask a doctor before use if": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks", "Stop use and ask a doctor if": "you have rectal bleeding or no bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a stool softener laxative for more than 1 week", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.", "Active ingredient (in each softgel)": "Docusate Sodium USP, 100 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information