FDA.reportPublic FDA data

Senna-Time

Manufacturer
McKesson Corporation dba SKY Packaging | McKesson Corporation dba RX Pak
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:42:57

Label at a glance#

ProductSenna-Time
Active ingredientSENNOSIDES A AND B
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains: Sennosides 8.6 mg

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

OTC - PURPOSE SECTION



PURPOSE: LAXATIVE

INDICATIONS & USAGE SECTION

Relieves occasional constipation (irregularity;generally causes bowel movement in 6-12 hours

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.

Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a day

Children 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a day

Children 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day

Children under 2 years - ask a doctor

WARNINGS SECTION

WARNINGS: Do not use laxative products for longer than 1 week unless directed by a doctor

INACTIVE INGREDIENT SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 63739-431

NDC: 63739-431-10 10 TABLET, COATED in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Senna-Time

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-431-102020-07-22C16284748780-1ab0e2407-2600-f274-e053-dbdaa90a64717a0b096b-ab37-4ffd-8d88-7f91e6ed60da

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
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJX1
SENNOSIDESACTIVE MOIETY3FYP5M0IJX1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704I1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H1

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
63739-43163739-431-10
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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
DIBASIC CALCIUM PHOSPHATE DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, COATED / ORAL488.7 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ICAPSULE / ORAL100 mgExact identifier — unii+route
2 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HTABLET, COATED / ORAL10 mgExact identifier — unii+route+dosage form
STARCH, TAPIOCASTARCH, TAPIOCA24SC3U704ITABLET / ORAL5 mgExact identifier — unii+route
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii+route+dosage form
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route+dosage form
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii+route+dosage form

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
bd229f16-8662-d63a-e053-2995a90a6f847a0b096b-ab37-4ffd-8d88-7f91e6ed60da2021-03-09WarningsExact identifier
spl set id: 7a0b096b-ab37-4ffd-8d88-7f91e6ed60da

Reported adverse events (FAERS/openFDA)#

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