drug facts

drug facts
SPL v4
SPL
SPL Set ID b52181e3-fd84-479e-8590-18619f6c0dae
Route
oral
Published
Effective Date 2024-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 red no. 40 fd&c yellow no. 6 hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified silicon dioxide sodium benzoate stearic acid talc titanium dioxide aluminum oxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-12-27

Purpose

Stool softener Laxative

Description

Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces 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 over 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 


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

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide

Description

Docusate sodium 50 mg Sennosides 8.6 mg

Principal Display Panel

Compare to the active ingredients in Senokot-S®†

Dual action

Senna Plus 

DOCUSATE SODIUM, 50 mg

SENNOSIDES, 8.6 mg

Laxative/Stool softener

Natural vegetable laxative ingredient plus stool softener

TABLETS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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 Labeling
CVS HEALTH Senna Plus
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 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 continues over a periodof 2 weeks 

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces 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 over 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 


Other Information (Other information)
  • each tablet contains: calcium 20 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)

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide

Principal Display Panel

Compare to the active ingredients in Senokot-S®†

Dual action

Senna Plus 

DOCUSATE SODIUM, 50 mg

SENNOSIDES, 8.6 mg

Laxative/Stool softener

Natural vegetable laxative ingredient plus stool softener

TABLETS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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 Labeling
CVS HEALTH Senna Plus
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 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 continues over a periodof 2 weeks 

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)