FDA.reportPublic FDA data

Regular Strength Laxative

Manufacturer
WinCo Foods LLC | TIME CAP LABORATORIES, INC.
Effective date
2022-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:28

Label at a glance#

ProductRegular Strength Laxative
Active ingredientSENNOSIDES
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides USP, 15 mg

OTC - PURPOSE SECTION

Purpose

Stimulant Laxative

INDICATIONS & USAGE SECTION

Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you

  • are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

OTC - WHEN USING SECTION

When using this product

  • do not use for a period longer than 1 week

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rectal bleeding or failure to have a bowel movement occur after use of a laxative.

These may 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• Swallow tablet(s) with a glass of water
• Swallow tablet(s) whole, do not crush, break, or chew.

adults and children 12 years of age and older take 2 tablets once or twice daily
children 6 to under 12 years of age take 1 tablet once or twice daily
children under 6 years of age ask a doctor

OTHER SAFETY INFORMATION

Other information
• each tablet contains: calcium 50 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredient acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, 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 - QUESTIONS SECTION

Questions? Call 1-800-824-1706
Monday – Friday 9am – 4pm MST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

190R-Winco-Regular-strength-carton-24s190R-Winco-Regular-strength-carton-24s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200162sennosides 15 MG Oral TabletPSN2
200162sennosides, USP 15 MG Oral TabletSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-384-242025-01-30C16284748780-12cef2736-955a-d83d-e063-dadaa90ab31f190R Winco Foods 67091 384 Sennosides USP 15 mg 24ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-384-24Regular Strength Laxative1 in 1 CARTONTABLET12
67091-384-24Regular Strength Laxative24 in 1 BLISTER PACKTABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-384REGULAR STRENGTH LAXATIVE (SENNOSIDES 15 MG) TABLET [WINCO FOODS LLC]2Legacy NDC, 2 package rows20220124_c34f225c-b41e-0138-e053-2a95a90a688c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-38467091-384-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SHELLAC46N107B71OIACT
SENNOSIDES3FYP5M0IJXACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
MALTODEXTRIN7CVR7L4A2DIACT
RAW SUGAR8M707QY5GHIACT
ACACIA5C5403N26OIACT
KAOLIN24H4NWX5COIACT
TALC7SEV7J4R1UIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MAGNESIUM STEARATE70097M6I30IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
FD&C RED NO. 40WZB9127XOAIACT

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
d50ce169-0f66-78d1-e053-2a95a90a8691c34f225c-b41e-0138-e053-2a95a90a688c2022-01-08WarningsExact identifier
spl id: d50ce169-0f66-78d1-e053-2a95a90a8691
spl set id: c34f225c-b41e-0138-e053-2a95a90a688c

Reported adverse events (FAERS/openFDA)#

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