Senna laxative

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:46:03

Label at a glance#

ProductSenna laxative
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

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 

Storage and handling

each tablet contains: calcium 25 mg store at 25 o C (77 o F); excursions permitted between 15 _ 30 o C (59 _ 86 o F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before using if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take preferably at bedtime or as directed by a doctor
agestarting 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

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 25 mg
  • store at 25oC (77o F); excursions permitted between 15_30oC (59_86oF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO SENOKOT® ACTIVE INGREDIENT†

Vegetable Laxative 

SENNOSIDES 8.6 mg • LAXATIVE

Gentle, Overnight Relief of Constipation

TABLETS

GLUTEN FREE

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH Vegetable Laxative
TOPCARE HEALTH Vegetable Laxative

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-786-01EA - Each36800-7867dc0f9a8-5b7c-4c71-8fda-60b1901e0fbd12018-02-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-78636800-786-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
476da1e4-4dd2-45ca-b994-cad477b0ef365786f514-c75f-4151-8820-e414163b08532024-06-20WarningsExact identifier
spl set id: 5786f514-c75f-4151-8820-e414163b0853

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.