Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: TCL097;PSD21;S44 Shape: round Color: red Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-12-31

Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Uses

for overnight relief from 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
childrens 6 to under 12 years of age	take1-2 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 now taking mineral oil, unless directed by a doctor

Product Label

QUALITY CHOICE Stool Softener Plus Stimulant Laxative

Other Information

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

Inactive Ingredients

carnauba wax*, 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*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the Active Ingredients in Colace® 2-IN-1

STOOL SOFTENER

Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable

TABLETS

†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.

Distributed by C.D.M.A. Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.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 may indicate 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 2 weeks

Structured Label Content

Uses

for overnight relief from 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
childrens 6 to under 12 years of age	take1-2 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 now taking mineral oil, unless directed by a doctor

Product Label

QUALITY CHOICE Stool Softener Plus Stimulant Laxative

Other Information

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

Inactive Ingredients (Inactive ingredients)

carnauba wax*, 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*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the Active Ingredients in Colace® 2-IN-1

STOOL SOFTENER

Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable

TABLETS

†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.

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.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 may indicate 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 2 weeks

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for overnight relief from 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 childrens 6 to under 12 years of age take1-2 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 now taking mineral oil, unless directed by a doctor", "Product Label": "QUALITY CHOICE Stool Softener Plus Stimulant Laxative", "Other Information": "each tablet contains : calcium 30 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 25ºC(77ºF), excursion permitted between 15-30ºC (59-86ºF)", "Inactive ingredients": "carnauba wax*, 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*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide *contains one or more of these ingredients", "Questions or comments?": "Call 1-248-449-9300 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "**Compare to the Active Ingredients in Colace® 2-IN-1 STOOL SOFTENER Plus Stimulant Laxative Docusate sodium, 50 mg Sennosides, 8.6 mg Effective Reliable Comfortable TABLETS †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 . Distributed by C.D.M.A. Inc.© 43157 W. 9 Mile Rd Novi, MI 48375 www.qualitychoice.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 may indicate 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 2 weeks"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information