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 2022-11-15 Until 2025-11-30

Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

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 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 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

compare to the active ingredient in Colace^® Regular Strength Stool Softener^†

^{docusate sodium}

docusate sodium 100 mg

stool softener laxative

gentle
dependable
stimulant-free

softgels

^†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace^® Regular Strength Stool Softener.

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

Distributed by:

MAJOR^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

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

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

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

Principal Dispaly Panel Unit Dose

Principal Dispaly Panel Bingo Card

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener laxative

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 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 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

compare to the active ingredient in Colace^® Regular Strength Stool Softener^†

^{docusate sodium}

docusate sodium 100 mg

stool softener laxative

gentle
dependable
stimulant-free

softgels

^†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace^® Regular Strength Stool Softener.

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

Distributed by:

MAJOR^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

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

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

ask a health care 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 (1-800-222-1222) right away.

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

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Principal Dispaly Panel Unit Dose (PRINCIPAL DISPALY PANEL - UNIT DOSE)

Principal Dispaly Panel Bingo Card (PRINCIPAL DISPALY PANEL - BINGO CARD)

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": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener laxative", "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 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 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 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "compare to the active ingredient in Colace ® Regular Strength Stool Softener † docusate sodium docusate sodium 100 mg stool softener laxative gentle dependable stimulant-free softgels † This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace ® Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com", "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", "If pregnant or breast-feeding,": "ask a health care professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredient (in each softgel)": "Docusate sodium 100 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information