FDA.reportPublic FDA data

191R Timely 49483 080 Sennosides 8.6 mg Tablets

Manufacturer
REMEDYREPACK INC.
Effective date
2021-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:37:01

Label at a glance#

ProductSENNA TIME
Active ingredientSENNOSIDES A AND B
Label structure13 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

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

DRUG: SENNA TIME

GENERIC: SENNOSIDES

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-3210-0

NDC: 70518-3210-1

COLOR: brown

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: TCL080

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

  • SENNOSIDES A AND B 8.6mg in 1

INACTIVE INGREDIENT(S):

  • CROSCARMELLOSE SODIUM
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE
  • HYPROMELLOSES
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • MINERAL OIL

Remedy_LabelRemedy_Label

MM2MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3210-02023-10-16C16284748780-1f386c649-c7a1-0266-e053-dadaa90a7c1a191R Timely 49483 080 Sennosides 8.6 mg Tablets
70518-3210-02023-01-30C16284748780-1f386c649-c7a1-0266-e053-dadaa90a7c1a191R Timely 49483 080 Sennosides 8.6 mg Tablets

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
70518-321070518-3210-1, 70518-3210-0
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
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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
07d7cfbd-69f8-4490-e063-6294a90a22cf5cc9e215-6191-4c70-9c4b-64a09fc92f7d2023-10-16WarningsExact identifier
spl set id: 5cc9e215-6191-4c70-9c4b-64a09fc92f7d

Reported adverse events (FAERS/openFDA)#

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