FDA.reportPublic FDA data

MAXIMUM STRENGTH LAXATIVE

Manufacturer
CARDINAL HEALTH | TIME CAP LABORATORIES, INC. | TIME CAP LABORATORIES, INC
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:04

Label at a glance#

ProductMAXIMUM STRENGTH LAXATIVE
Active ingredientSENNOSIDES
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Each Tablet contains:

SENNOSIDES,USP 25 mg

INACTIVE INGREDIENTS

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, 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 - PURPOSE SECTION

PURPOSE:

Stimulant Laxative

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.

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE

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

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 12years 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 COUNT24 COUNT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251292sennosides 25 MG Oral TabletPSN3
251292sennosides, USP 25 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0077-1MAXIMUM STRENGTH LAXATIVE24 in 1 BLISTER PACKTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0077MAXIMUM STRENGTH LAXATIVE (SENNOSIDES) TABLET [CARDINAL HEALTH]3Current NDC, Legacy NDC, 1 package rows20240112_b7b13bfa-8a94-6f62-e053-2995a90abbf4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0077-1EA - Each70000-0077e3020714-fd50-4fdf-9a36-d8461bfd0c8912021-06-02

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-007770000-0077-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE029TFK992NIACT
FERROUS OXIDEG7036X8B5HIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
KAOLIN24H4NWX5COIACT
RAW SUGAR8M707QY5GHIACT
ACACIA5C5403N26OIACT
SENNOSIDES3FYP5M0IJXACTIB
FERROSOFERRIC OXIDEXM0M87F357IACT
STEARIC ACID4ELV7Z65APIACT
MALTODEXTRIN7CVR7L4A2DIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SHELLAC46N107B71OIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
ndc (package): 70000-0077-1
ndc (product): 70000-0077
ndc11 (package): 70000007701
spl id: 0ea4ae4b-da7f-7127-e063-6294a90a9af2
spl set id: b7b13bfa-8a94-6f62-e053-2995a90abbf4

Reported adverse events (FAERS/openFDA)#

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