FDA.reportPublic FDA data

CVS Health Regular Strength Senna Laxative SOFTGEL

Manufacturer
CVS Pharmacy, Inc.
Effective date
2024-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:04

Label at a glance#

ProductCVS Health Regular Strength Senna Laxative SOFTGEL
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 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

• store at room temperature between 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

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

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

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.

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.

Age Starting Dosage Maximum Dosage
 adults and children 12 years of age and over 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

Other information

STORAGE AND HANDLING SECTION

• store at room temperature between 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

black Iron oxide, fumaric acid, gelatin, glycerin, lecithin, methyl paraben, purified water, red Iron oxide, sorbitol 70% solution, soybean oil, yellow bees wax

Questions?

OTC - QUESTIONS SECTION

Call 1-800-SHOP-CVS

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Senokot®*

Liquid Filled Softgels

Standardized senna concentrate

Natural vegetable laxative ingredient

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®.

Package contains one bottle

Overnight, gentle laxative

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2024 CVS/pharmacy
CVS.com® 1-800-SHOP-CVS

Product of India

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS-901CVS-901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
476827sennosides 8.6 MG Oral CapsulePSN1
476827sennosides, USP 8.6 MG Oral CapsuleSCD1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-901-06CVS Health Regular Strength Senna Laxative SOFTGEL1 in 1 CARTONCAPSULE, LIQUID FILLED11
51316-901-06CVS Health Regular Strength Senna Laxative SOFTGEL60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-901CVS HEALTH REGULAR STRENGTH SENNA LAXATIVE SOFTGEL (SENNOSIDES) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]12 package rows20240131_5d4895f2-815d-440a-a5f7-45df453dc274.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-90151316-901-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
FUMARIC ACID88XHZ13131IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675IACT
SORBITOL506T60A25RIACT
SOYBEAN OIL241ATL177AIACT
YELLOW WAX2ZA36H0S2VIACT

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
97ce4859-8473-441b-8bda-7e24d821e1875d4895f2-815d-440a-a5f7-45df453dc2742024-01-16WarningsExact identifier
spl id: 97ce4859-8473-441b-8bda-7e24d821e187
spl set id: 5d4895f2-815d-440a-a5f7-45df453dc274

Reported adverse events (FAERS/openFDA)#

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