FDA.reportPublic FDA data

190R Sennosides tablets USP 15 mg sugar coated off-white

Manufacturer
TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:13

Label at a glance#

ProductSENNOSIDES
Active ingredientSENNOSIDES A AND B
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each Tablet contains:

Sennosides 15 mg

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide

OTC - PURPOSE SECTION

stool softner, laxative

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 (not to 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 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

INDICATIONS & USAGE SECTION

Uses:

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

WARNINGS SECTION

WARNINGS:

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 - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 49483-079-00

TCL 190RTCL 190R

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200162sennosides 15 MG Oral TabletPSN3
200162sennosides, USP 15 MG Oral TabletSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49483-079-002025-02-13C16284748780-12cef2736-a6ca-d83d-e063-dadaa90ab31f190R Sennosides tablets USP 15 mg sugar coated off-white
49483-079-012025-02-13C16284748780-12cef2736-a6ca-d83d-e063-dadaa90ab31f190R Sennosides tablets USP 15 mg sugar coated off-white
49483-079-002025-01-30C16284748780-12cef2736-a6ca-d83d-e063-dadaa90ab31f190R Sennosides tablets USP 15 mg sugar coated off-white
49483-079-012025-01-30C16284748780-12cef2736-a6ca-d83d-e063-dadaa90ab31f190R Sennosides tablets USP 15 mg sugar coated off-white

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-079-00SENNOSIDES50000 in 1 CARTONTABLET, SUGAR COATED500003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-079SENNOSIDES TABLET, SUGAR COATED [TIME CAP LABORATORIES, INC]3Current NDC, Legacy NDC, 1 package rows20250215_7498f5fa-1739-bb6e-e053-2a91aa0a5404.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49483-07949483-079-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
KAOLIN24H4NWX5COIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
RAW SUGAR8M707QY5GHIACT
TALC7SEV7J4R1UIACT
ACACIA5C5403N26OIACT
SENNOSIDES A AND B1B5FPI42ENACTIB
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
ndc (package): 49483-079-00
ndc (product): 49483-079
ndc11 (package): 49483007900
spl id: 2d9b5338-d4a2-596d-e063-6294a90ac880
spl set id: 7498f5fa-1739-bb6e-e053-2a91aa0a5404

Reported adverse events (FAERS/openFDA)#

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