FDA.reportPublic FDA data

191R RITE AID 11822 3311 SENNA LAXATIVE TABLETS

Manufacturer
RITE AID | TIME CAP LABORATORIES, INC.
Effective date
2021-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:37

Label at a glance#

ProductSENNA
Active ingredientSENNOSIDES A AND B
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Sennosides 8.6 mg

OTC - PURPOSE SECTION


Purpose

Laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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.

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 (do not exceed maximum dosage) or decrease dose until you are comfortable
      age

      starting

      dosage

      maximum

      dosage

      adults and children 12 years and over

      		2 tablets once a day4 tablets twice a day
      children 6 to under 12 years1 tablet once a day2 tablets twice a day
      children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
      children under 2 yearsask a doctorask a doctor

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°- 30°C (59°- 86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

191R-Rite Aid-Laxative Senna Tablets-bottle label-100s191R-Rite Aid-Laxative Senna Tablets-bottle label-100s191R-Rite Aid-Laxative Senna Tablets-carton label-100s191R-Rite Aid-Laxative Senna Tablets-carton label-100s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN2
312935sennosides, USP 8.6 MG Oral TabletSCD2
312935sennosides A and B 8.6 MG Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3311-52025-01-30C16284748780-12cef2736-7874-d83d-e063-dadaa90ab31f191R RITE AID 11822 3311 SENNA LAXATIVE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3311-5SENNA100 in 1 BOTTLE, PLASTICTABLET, COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3311SENNA (SENNOSIDES) TABLET, COATED [RITE AID]2Legacy NDC, 1 package rows20211031_ad407c0d-8e13-873f-e053-2995a90aa8fa.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-331111822-3311-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
SENNOSIDES A AND B1B5FPI42ENACTIB

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
cf693c9e-9b3e-44da-e053-2a95a90ad2e9ad407c0d-8e13-873f-e053-2995a90aa8fa2021-10-28WarningsExact identifier
spl id: cf693c9e-9b3e-44da-e053-2a95a90ad2e9
spl set id: ad407c0d-8e13-873f-e053-2995a90aa8fa

Reported adverse events (FAERS/openFDA)#

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