FDA.reportPublic FDA data

Maximum 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#

ProductMaximum Strength Laxative
Active ingredientSENNOSIDES
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sennosides USP, 25 mg

OTC - PURPOSE SECTION

Stimulant Laxative

INDICATIONS & USAGE SECTION

Uses

• relieves occasional constipation (irregularity)

• generally produces bowel movement in 6 to 12 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 40 mg, sodium 2 mg (VERY LOW SODIUM)
• store between 20°-25°C (68°-77°F).

INACTIVE INGREDIENT SECTION

Inactive ingredients

​acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminium lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

195R-Winco-Max-Strength-Laxative-carton-24s195R-Winco-Max-Strength-Laxative-carton-24s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251292sennosides 25 MG Oral TabletPSN2
251292sennosides, USP 25 MG Oral TabletSCD2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67091-383-242025-01-30C16284748780-12cef2736-6bae-d83d-e063-dadaa90ab31f195R Winco Foods 67091 383 Sennosides USP 25 mg 24ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-383-24Maximum Strength Laxative1 in 1 CARTONTABLET12
67091-383-24Maximum Strength Laxative24 in 1 BLISTER PACKTABLET242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-383MAXIMUM STRENGTH LAXATIVE (SENNOSIDES 25 MG) TABLET [WINCO FOODS LLC]2Legacy NDC, 2 package rows20220124_c34f0c68-9a77-58ab-e053-2a95a90a12fe.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-38367091-383-24

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
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SHELLAC46N107B71OIACT
RAW SUGAR8M707QY5GHIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SENNOSIDES3FYP5M0IJXACTIB
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
STARCH, CORNO8232NY3SJIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MALTODEXTRIN7CVR7L4A2DIACT
STEARIC ACID4ELV7Z65APIACT
KAOLIN24H4NWX5COIACT
POVIDONEFZ989GH94EIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ACACIA5C5403N26OIACT
CARNAUBA WAXR12CBM0EIZIACT

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
d50f6aa7-9f85-7b2f-e053-2a95a90a050bc34f0c68-9a77-58ab-e053-2a95a90a12fe2022-01-08WarningsExact identifier
spl id: d50f6aa7-9f85-7b2f-e053-2a95a90a050b
spl set id: c34f0c68-9a77-58ab-e053-2a95a90a12fe

Reported adverse events (FAERS/openFDA)#

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