Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg) Sennosides (8.6 mg)

Inactive Ingredients

Carnauba Wax Croscarmellose Sodium D&c Yellow No. 10 Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 2 Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Sodium Benzoate Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: TCL081;0805;AV;S35 Shape: round Color: orange Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-11-30

Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses

relieves occasional constipation (irregularity)
generally causes bowel movement in 6- 12 hours.

Directions

Take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Do Not Use

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

Product Label

Quality Choice Stool Softener Orange Tablets

Other Information

each tablet contains: calcium 20 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and 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 Senokot-S®

Stool Softener plus laxative

Stool Softener • Laxative

Docusate Sodium, 50 mg/ Sennosides, 8.6 mg

Provides Gentle Relief of: Occasional Constipation

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

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 Breastfeeding,

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 continues over a period of 2 weeks.

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally causes bowel movement in 6- 12 hours.

Purpose

Stool softener

Laxative

Directions

Take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Do Not Use (Do not use)

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

Product Label

Quality Choice Stool Softener Orange Tablets

Other Information (Other information)

each tablet contains: calcium 20 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and 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 Senokot-S®

Stool Softener plus laxative

Stool Softener • Laxative

Docusate Sodium, 50 mg/ Sennosides, 8.6 mg

Provides Gentle Relief of: Occasional Constipation

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

43157 W. Nine Mile

Novi, MI 48376-0995

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 Breastfeeding, (If pregnant or breastfeeding,)

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 continues 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 causes bowel movement in 6- 12 hours.", "Purpose": "Stool softener Laxative", "Directions": "Take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor", "Do not use": "If you are now taking mineral oil, unless directed by a doctor laxative products for longer than 1 week unless directed by a doctor", "Product Label": "Quality Choice Stool Softener Orange Tablets", "Other information": "each tablet contains: calcium 20 mg each tablet contains : sodium 6 mg VERY LOW SODIUM store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)", "Inactive Ingredients": "carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and 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 Senokot-S® Stool Softener plus laxative Stool Softener • Laxative Docusate Sodium, 50 mg/ Sennosides, 8.6 mg Provides Gentle Relief of: Occasional Constipation Tablets †This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by C.D.M.A., Inc© 43157 W. Nine Mile Novi, MI 48376-0995 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 breastfeeding,": "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 continues 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