FDA.reportPublic FDA data

Maximum Strength Senna Laxative

Manufacturer
NUVICARE LLC
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:19

Label at a glance#

ProductMaximum Strength Senna Laxative
Active ingredientSENNOSIDES
Label structure14 sections

Indications and uses

relieves occasional constipation (irregularity). generally prodcues a bowel movement in 6-12 hours

Dosage and administration

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: 2 tablets once or twice daily children 6 to under 12 years of age: 1 tablet once or twice daily children under 6 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 25 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses:

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity).
  • generally prodcues a bowel movement in 6-12 hours

Warnings:

WARNINGS 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.

Ask a doctor or pharmacist before use if 

  • you are taking 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 (1-800-222-1222) right away. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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: 2 tablets once or twice daily
  • children 6 to under 12 years of age: 1 tablet once or twice daily
  • children under 6 years of age: ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • each tablet contains: Calcium 27 mg, Magnesium 0.16 mg, Sodium 0.81 mg  
  • store at controlled room temperature 20-25°C (68-77°F) 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Dicalcium Phosphate/Dibasic Calcium Phosphate, Croscarmellose Sodium, Sodium Lauryl sulphate, Colloidal Silicon Dioxide, Crospovidone, Stearic acid powder, Magnesium Stearate, Brilliant Blue Lake, Indigo Carmine Lake, Polyvinly Alcohol, Polyethylene Glycol, Titanium Dioxide, Talc

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or email: support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0285-00-NC-Senna 60ct-signedPL0285-00-NC-Senna 60ct-signed

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251292sennosides 25 MG Oral TabletPSN1
251292sennosides, USP 25 MG Oral TabletSCD1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130384324000435GTIN-13: 0384324000435
EAN-13: 0384324000435
GTIN-12: 384324000435
UPC-A: 384324000435
GTIN storage (14 digits): 00384324000435		PL0285-00-NC-Senna 60ct-signed.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-033-01Maximum Strength Senna Laxative60 in 1 BOTTLETABLET601

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-03384324-033-01

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
SENNOSIDES3FYP5M0IJXACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
INDIGOTINDISULFONATE SODIUMD3741U8K7LIACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT

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 Senna LaxativeSENNOSIDE 25 MGNUVICARE LLCa2a3b83f-2d49-4bc4-90d7-1f2a7f4ea45f2026-01-22WarningsExact identifier
ndc (package): 84324-033-01
ndc (product): 84324-033
ndc11 (package): 84324003301
spl id: caaad95a-c75a-4269-9d46-55a55d9353e6
spl set id: a2a3b83f-2d49-4bc4-90d7-1f2a7f4ea45f

Reported adverse events (FAERS/openFDA)#

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