Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Talc Titanium Dioxide Aluminum Oxide Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance

Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-30

Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to12 hours

Directions

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and older	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Do Not Use

laxative products for longer than 1 week unless directed by a doctor
if you are presently taking mineral oil, unless directed by a doctor

Product Label

TOPCARE HEALTH Stool Softener Laxative

Other Information

each tablet contains: calcium 30 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc*, titanium dioxide

Questions Or Comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT†

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg STOOL SOFTENER

SENNOSIDES 8.6 mg STIMULANT LAXATIVE

For Overnight Relief Of Occasional Constipation

Effective
Reliable
Comfortable

TABLETS

GLUTEN FREE

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1

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: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.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.

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 right away.

Active Ingredients (in Each Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to12 hours

Purpose

Stool softener

Stimulant laxative

Directions

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and older	take 2-4 tablets daily
children 6 to under 12 years of age	take 1-2 tablets daily
children 2 to under 6 years of age	take up to 1 tablet daily
children under 2	ask a doctor

Do Not Use (Do not use)

laxative products for longer than 1 week unless directed by a doctor
if you are presently taking mineral oil, unless directed by a doctor

Product Label

TOPCARE HEALTH Stool Softener Laxative

Other Information (Other information)

each tablet contains: calcium 30 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc*, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT†

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg STOOL SOFTENER

SENNOSIDES 8.6 mg STIMULANT LAXATIVE

For Overnight Relief Of Occasional Constipation

Effective
Reliable
Comfortable

TABLETS

GLUTEN FREE

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1

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: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.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.

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 right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Docusate sodium 50 mg

Sennosides 8.6 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 a period of 2 weeks

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 6 to12 hours", "Purpose": "Stool softener Stimulant laxative", "Directions": "Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and older take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor ", "Do not use": "laxative products for longer than 1 week unless directed by a doctor if you are presently taking mineral oil, unless directed by a doctor", "Product Label": "TOPCARE HEALTH Stool Softener Laxative", "Other information": "each tablet contains : calcium 30 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc*, titanium dioxide", "Questions or comments?": "Call toll free 1-888-423-0139", "Principal Display Panel": "COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT† Stool Softener Plus Stimulant Laxative DOCUSATE SODIUM 50 mg STOOL SOFTENER SENNOSIDES 8.6 mg STIMULANT LAXATIVE For Overnight Relief Of Occasional Constipation Effective Reliable Comfortable TABLETS GLUTEN FREE †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1 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: TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 topcare@topco.com www.topcarebrand.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.", "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 right away.", "Active ingredients (in each tablet)": "Docusate sodium 50 mg Sennosides 8.6 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information