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 Sorbitan

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-08-02

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

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

Directions

take with a glass of water

adults and children 12 years and over	take 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	take 1 softgel daily
children under 2 years of age	ask a doctor

Do Not Use

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

Product Label

CAREONE Stool Softener Laxative

Other Information

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

Inactive Ingredients

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

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener†

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION

SOFTGELS

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 FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Questions Or Comments ?

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

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after using laxative. These could be signs 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

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Uses

for relief of occasional constipation and irregularity
this product generally produces a 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 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	take 1 softgel daily
children under 2 years of age	ask a doctor

Do Not Use (Do not use)

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

Product Label

CAREONE Stool Softener Laxative

Other Information (Other information)

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

Inactive Ingredients

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

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener†

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION

SOFTGELS

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 FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Questions Or Comments ? (Questions or Comments ?)

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

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

you have rectal bleeding or no bowel movement after using laxative. These could be signs 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

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

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation and irregularity this product generally produces a 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 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 take 1 softgel daily children under 2 years of age ask a doctor", "Do not use": "if you are presently taking mineral oil, unless directed by a doctor", "Product Label": "CAREONE Stool Softener Laxative", "Other information": "each softgel contains: sodium 5 mg store at 25 o C (77 o ); excursions permitted between 15-30 o C (59-86 o F)", "Inactive Ingredients": "edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol", "Principal Display Panel": "Compare to the active ingredient in Dulcolax® Stool Softener† STOOL SOFTENER LAXATIVE Docusate Sodium 100 mg FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION SOFTGELS 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 FOODHOLD U.S.A., LLC LANDOVER, MD 20785", "Questions or Comments ?": "Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST", "Stop use and ask a doctor if": "you have rectal bleeding or no bowel movement after using laxative. These could be signs 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", "Ask a doctor before use if you have": "stomach pain nausea vomiting a sudden change in bowel habits that lasts more than 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information