Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

D&c Red No. 33 Gelatin Type B Bovine (160 Bloom) Glycerin Fd&c Red No. 40 Fd&c Yellow No. 6 Sorbitol Polyethylene Glycol 400 Propylene Glycol Water Shellac Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: Q04 Shape: oval Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-02-08

Medication Information

Purpose

Stool softener

Description

(in each softgel) Docusate sodium 100 mg

Uses

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

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor

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 softgel daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Active Ingredient

(in each softgel)

Docusate sodium 100 mg

Other Information

each capsule contains: sodium 5 mg Very Low Sodium
store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Inactive Ingredients

D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions Or Comments?

Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)

^*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace^®.

DISTRIBUTED BY

SAM'S WEST, INC.

BENTONVILLE, AR 72716

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 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.

Ask A Doctor Before Use If You Have

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

Package Label Principal Display Panel 100 Mg (600 capsules Container Label)

Compare to Colace^®

active ingredient^*

NDC 68196-995-64

Member's Mark_™

Stool

Softener

Docusate sodium 100 mg

Regular Strength

Gentle, Dependable
Stimulant-free

600 Softgels

Structured Label Content

Uses

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

Purpose

Stool softener

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor

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 softgel daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Active Ingredient (Active ingredient)

(in each softgel)

Docusate sodium 100 mg

Other Information (Other information)

each capsule contains: sodium 5 mg Very Low Sodium
store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.

Inactive Ingredients (Inactive ingredients)

D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

Questions Or Comments? (Questions or Comments?)

Call 1-855-274-4122 (toll-free)

(Monday - Friday 8:30 AM to 5:00 PM EST)

^*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace^®.

DISTRIBUTED BY

SAM'S WEST, INC.

BENTONVILLE, AR 72716

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 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.

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

Package Label Principal Display Panel 100 Mg (600 capsules Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label))

Compare to Colace^®

active ingredient^*

NDC 68196-995-64

Member's Mark_™

Stool

Softener

Docusate sodium 100 mg

Regular Strength

Gentle, Dependable
Stimulant-free

600 Softgels

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN TYPE B BOVINE (160 BLOOM)", "unii": "1T8387508X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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": "SHELLAC", "unii": "46N107B71O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "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", "Warnings": "Do not use if you are presently taking mineral oil, unless told to do so by a doctor", "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 softgel daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor", "Active ingredient": "(in each softgel) Docusate sodium 100 mg", "Other information": "each capsule contains: sodium 5 mg Very Low Sodium store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.", "Inactive ingredients": "D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.", "Questions or Comments?": "Call 1-855-274-4122 (toll-free) (Monday - Friday 8:30 AM to 5:00 PM EST) * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace ® . DISTRIBUTED BY SAM'S WEST, INC. BENTONVILLE, AR 72716", "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 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.", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)": "Compare to Colace ® active ingredient * NDC 68196-995-64 Member's Mark ™ Stool Softener Docusate sodium 100 mg Regular Strength Gentle, Dependable Stimulant-free 600 Softgels"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information