FDA.reportPublic FDA data

SENNA

Manufacturer
CVS
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:04

Label at a glance#

ProductSENNA
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces 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 or older 2 softgels once a day 4 softgels twice a day children 6 to under 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor

Storage and handling

each softgel contains: calcium 1 mg and sodim less than 1  mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each softgel)                                    Purpose

Sennosides 8.6 mg..............................................................Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces 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 use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 DosageMaximum Dosage
adults and children 12 years of age or older2 softgels once a day4 softgels twice a day
children 6 to under 12 years1 softgel once a day2 softgels twice a day
children under 6 years of ageask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: calcium 1 mg and sodim less than 1  mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aerosil, beeswax, FD&C Red No. 33, FD&C Yellow No.6, gelatin, glycerin, light liquid paraffin, purified water, sodium carboxymethyl cellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVSHealth ™

Compare to the active
ingredient in Senokot ®*

Liquid Filled Softgels†

NDC 69842-320-60

Senna
SENNOSIDES, 8.6 mg
Laxative

Standardized senna concentrate

Natural vegetable

laxative ingredient

60 SOFTGELS

Actual Product Size

on Bottom Panel

PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton
PRINCIPAL DISPLAY PANEL - CVS SENNA 60 Softgels Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476827sennosides 8.6 MG Oral CapsulePSN7
476827sennosides, USP 8.6 MG Oral CapsuleSCD7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-320-60SENNA1 in 1 CARTONCAPSULE, GELATIN COATED17
69842-320-60SENNA60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-320SENNA (SENNOSIDES) CAPSULE, GELATIN COATED [CVS]7Legacy NDC, 2 package rows20241218_f5bc4fda-11be-450c-9a67-57681a7a0aec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-320-60EA - Each69842-3209fa7ad0b-a863-43a5-9e89-709535b8989412024-08-12

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-32069842-320-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SENNOSIDES3FYP5M0IJXACTIB

Source Document#

Source XML · Source PDF

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
2968b71c-44f1-e45e-e063-6394a90acdb2f5bc4fda-11be-450c-9a67-57681a7a0aec2024-12-16WarningsExact identifier
spl id: 2968b71c-44f1-e45e-e063-6394a90acdb2
spl set id: f5bc4fda-11be-450c-9a67-57681a7a0aec

Reported adverse events (FAERS/openFDA)#

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