Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: P51 Shape: oval Color: orange Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-01-31

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

relieves occasional constipation and 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 over 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.

Product Label

CVS HEALTH Stool Softener

Other Information

each softgel contains: sodium 5 mg
store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

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†

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Gentle, softener relief

SOFTGELS

†This product is not manufactured or distributed by Avrio HealthL.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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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 fail to have a bowel movement after using a laxative. These could be a sign of a serious condition
you need to use a 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 right away.

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Structured Label Content

Uses

relieves occasional constipation and 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 over 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.

Product Label

CVS HEALTH Stool Softener

Other Information (Other information)

each softgel contains: sodium 5 mg
store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

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†

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool Softener Laxative

Gentle, softener relief

SOFTGELS

†This product is not manufactured or distributed by Avrio HealthL.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: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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 fail to have a bowel movement after using a laxative. These could be a sign of a serious condition
you need to use a 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 right away.

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

Docusate Sodium 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": "SORBITAN", "unii": "6O92ICV9RU", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation and 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 over 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.", "Product Label": "CVS HEALTH Stool Softener", "Other information": "each softgel contains: sodium 5 mg store 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)", "Inactive ingredients": "edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol", "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† Stool Softener DOCUSATE SODIUM, 100 mg Stool Softener Laxative Gentle, softener relief SOFTGELS †This product is not manufactured or distributed by Avrio HealthL.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: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895", "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 fail to have a bowel movement after using a laxative. These could be a sign of a serious condition you need to use a 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 right away.", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information