Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide D&c Red No. 33 Ferrosoferric Oxide

Identifiers & Packaging

Pill Appearance

Imprint: P10 Shape: oval Color: red Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-03-26

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement within 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 so by a doctor.

Product Label

CAREONE Stool Softener Laxative

Other Information

each softgel contains: sodium 6 mg
store at 25^oC (77^o F); excursions permitted between 15- 30^oC (59^o- 86^o F)

Inactive Ingredients

black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

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

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

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: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

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 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

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement within 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 so by a doctor.

Product Label

CAREONE Stool Softener Laxative

Other Information (Other information)

each softgel contains: sodium 6 mg
store at 25^oC (77^o F); excursions permitted between 15- 30^oC (59^o- 86^o F)

Inactive Ingredients

black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

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

STOOL SOFTENER LAXATIVE

Docusate Sodium 100 mg

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: FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

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 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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces a bowel movement within 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 so by a doctor.", "Product Label": "CAREONE Stool Softener Laxative", "Other information": "each softgel contains: sodium 6 mg store at 25 o C (77 o F); excursions permitted between 15- 30 o C (59 o - 86 o F)", "Inactive Ingredients": "black iron oxide, D&C Red #33, FD&C blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide", "Principal Display Panel": "Compare to the active ingredient in Colace® Regular Strength Stool Softener† STOOL SOFTENER LAXATIVE Docusate Sodium 100 mg 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: FOODHOLD U.S.A., LLC LANDOVER, MD 20785", "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 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