FDA.reportPublic FDA data

191R Timely 49483 080 Sennosides 8.6 mg Tablets

Manufacturer
TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2025-02-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:54:45

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

OTC - DO NOT USE SECTION

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

OTHER INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

191R-100ct label191R-100ct label

191R-1000ct label191R-1000ct label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
763296Senna-Time 8.6 MG Oral TabletPSN7
312935sennosides 8.6 MG Oral TabletPSN7
763296sennosides, USP 8.6 MG Oral Tablet [Senna-Time]SBD7
312935sennosides, USP 8.6 MG Oral TabletSCD7
763296Senna-Time 8.6 MG Oral TabletSY7
312935sennosides A and B 8.6 MG Oral TabletSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-080-002025-02-10C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets
49483-080-012025-02-10C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets
49483-080-102025-02-10C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets
49483-080-002025-01-30C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets
49483-080-012025-01-30C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets
49483-080-102025-01-30C16284748780-12cef2736-b2cf-d83d-e063-dadaa90ab31f191R Timely 49483 080 Sennosides 8.6 mg Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-080-00SENNA TIME100000 in 1 CARTONTABLET, COATED1000007
49483-080-01SENNA TIME100 in 1 BOTTLE, PLASTICTABLET, COATED1007
49483-080-10SENNA TIME1000 in 1 BOTTLE, PLASTICTABLET, COATED10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-080SENNA TIME (SENNOSIDES) TABLET, COATED [TIME CAP LABORATORIES, INC]7Current NDC, Legacy NDC, 3 package rows20250212_18ec8127-422c-4c1a-8331-58dabce69969.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42EN1
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42EN1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1

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
49483-08049483-080-01, 49483-080-00, 49483-080-10

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
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
ndc (package): 49483-080-00
ndc (package): 49483-080-01
ndc (package): 49483-080-10
ndc (product): 49483-080
ndc11 (package): 49483008010
ndc11 (package): 49483008001
ndc11 (package): 49483008000
spl id: 2d9b792b-a932-6981-e063-6294a90af7ef
spl set id: 18ec8127-422c-4c1a-8331-58dabce69969

Reported adverse events (FAERS/openFDA)#

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