FDA.reportPublic FDA data

SENNA TIME

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2024-07-25
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:17:31

Label at a glance#

ProductSENNA TIME
Active ingredientSENNOSIDES A AND B
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose
Laxative

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings
Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

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.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable

age

Starting dosageMaximum dosage
adults and children 12 years and over2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

SPL UNCLASSIFIED SECTION

Other information ­

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

OTC - QUESTIONS SECTION

Questions or comments: call 1-877-290-4008

SPL UNCLASSIFIED SECTION

191R  1121

Manufactured by: Time-Cap Labs, Inc.

7 Michael Avenue, Farmingdale, NY 11735

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
763296Senna-Time 8.6 MG Oral TabletPSN11
312935sennosides 8.6 MG Oral TabletPSN11
763296sennosides, USP 8.6 MG Oral Tablet [Senna-Time]SBD11
312935sennosides, USP 8.6 MG Oral TabletSCD11
763296Senna-Time 8.6 MG Oral TabletSY11
312935sennosides A and B 8.6 MG Oral TabletSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8402-05SENNA TIME15 in 1 BLISTER PACKTABLET, COATED1511
0615-8402-39SENNA TIME30 in 1 BLISTER PACKTABLET, COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8402SENNA TIME (SENNOSIDES) TABLET, COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]11Current NDC, Legacy NDC, 2 package rows20240821_c1aa28e7-2c7e-4fbd-842d-11082fbcbfe6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-080-01EA - Each49483-0802a975f41-459c-40f7-bd31-b959b44eb14d12012-07-24
49483-080-10EA - Each49483-08013d69fcc-a762-4953-9a30-e27716d917a012012-07-24

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-84020615-8402-39, 0615-8402-05
49483-080

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
ndc (product): 49483-080
SENNA TIMESENNOSIDESNCS HealthCare of KY, LLC dba Vangard Labsc1aa28e7-2c7e-4fbd-842d-11082fbcbfe62024-07-25WarningsExact identifier
ndc (package): 0615-8402-05
ndc (package): 0615-8402-39
ndc (product): 0615-8402
ndc11 (package): 00615840239
ndc11 (package): 00615840205
spl id: fda7565f-7224-46a0-b3cc-d3b9d4fbb373
spl set id: c1aa28e7-2c7e-4fbd-842d-11082fbcbfe6

Reported adverse events (FAERS/openFDA)#

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