FDA.reportPublic FDA data

192R Timely 49483 081 Docusate sodium 50 mg 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
5
Source
full-release
Hydrated at
2026-06-01 00:54:52

Label at a glance#

ProductSENNA TIME S
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener

Stimulant 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

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • 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
  • a sudden change in bowel movements that persists over 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 could be signs of 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 the 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
agestarting dosagemaximum dosage
adults and children 12 years of age and older2 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 years½ tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

192R-Timely-SennaS-1000-bottle-label192R-Timely-SennaS-1000-bottle-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-081-002025-02-10C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets
49483-081-012025-02-10C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets
49483-081-102025-02-10C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets
49483-081-002025-01-30C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets
49483-081-012025-01-30C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets
49483-081-102025-01-30C16284748780-12cef2736-91d6-d83d-e063-dadaa90ab31f192R Timely 49483 081 Docusate sodium 50 mg Sennosides 8.6 mg tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-081-00SENNA TIME S100000 in 1 CARTONTABLET, FILM COATED1000005
49483-081-01SENNA TIME S100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
49483-081-10SENNA TIME S1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-081SENNA TIME S (DOCUSATE SODIUM-SENNOSIDES) TABLET, FILM COATED [TIME CAP LABORATORIES, INC]5Current NDC, Legacy NDC, 3 package rows20250212_dc491692-8d3a-4ccd-a17d-4c630f122595.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-081-01EA - Each49483-081dbdee621-03c3-4233-a3c3-0f61f051156012015-08-04
49483-081-10EA - Each49483-0810e50bc4b-d558-4109-9045-614e8955a3bc12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA01
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42EN1
DOCUSATEACTIVE MOIETYM7P27195AG1
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42EN1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-08149483-081-01, 49483-081-10, 49483-081-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT

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 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, FILM COATED / ORAL120 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 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 TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
ndc (package): 49483-081-01
ndc (package): 49483-081-10
ndc (package): 49483-081-00
ndc (product): 49483-081
ndc11 (package): 49483008101
ndc11 (package): 49483008100
ndc11 (package): 49483008110
spl id: 2d9be614-4a58-f242-e063-6294a90a1743
spl set id: dc491692-8d3a-4ccd-a17d-4c630f122595

Reported adverse events (FAERS/openFDA)#

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