FDA.reportPublic FDA data

192R Rite aid 11822 3065 DOC SOD 50MG/SENNOSIDES 8.6MG TABLETS

Manufacturer
RITE AID | TIME CAP LABORATORIES, INC
Effective date
2023-04-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:45

Label at a glance#

ProductSENNA-S
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docustate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener

Stimulant 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

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have to have a bowel movement after use of a laxative. These could 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 over2 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 years½ 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 20 mg, sodium 6 mg (LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yelow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

192R-RA-laxative-30s-label192R-RA-laxative-30s-label192R-RA-laxative-30s-ifc192R-RA-laxative-30s-ifc192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-60s192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-60s192R-Rite Aid-Laxative Stool Softner Tablets-carton label-60s192R-Rite Aid-Laxative Stool Softner Tablets-carton label-60s192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-120s192R-Rite Aid-Laxative Stool Softner Tablets-bottle label-120s192R-Rite Aid-Laxative Stool Softner Tablets-carton label-120s192R-Rite Aid-Laxative Stool Softner Tablets-carton label-120s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-3065-32025-01-30C16284748780-12cef2736-9acf-d83d-e063-dadaa90ab31f192R Rite aid 11822 3065 DOC SOD 50MG/SENNOSIDES 8.6MG TABLETS
11822-3065-62025-01-30C16284748780-12cef2736-9acf-d83d-e063-dadaa90ab31f192R Rite aid 11822 3065 DOC SOD 50MG/SENNOSIDES 8.6MG TABLETS
11822-3065-92025-01-30C16284748780-12cef2736-9acf-d83d-e063-dadaa90ab31f192R Rite aid 11822 3065 DOC SOD 50MG/SENNOSIDES 8.6MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3065-3SENNA-S60 in 1 BOTTLETABLET, COATED604
11822-3065-6SENNA-S120 in 1 BOTTLE, PLASTICTABLET, COATED1204
11822-3065-9SENNA-S30 in 1 BOTTLETABLET, COATED304
11822-3065-9SENNA-S1 in 1 CARTONTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3065SENNA-S (DOCUSATE SODIUM AND SENNOSIDES) TABLET, COATED [RITE AID]4Legacy NDC, 4 package rows20230422_ad4fdeec-27f6-33cf-e053-2995a90a1519.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-306511822-3065-3, 11822-3065-6, 11822-3065-9

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
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT

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
f9c1d61a-e514-8063-e053-6294a90a79eaad4fdeec-27f6-33cf-e053-2995a90a15192023-04-20WarningsExact identifier
spl id: f9c1d61a-e514-8063-e053-6294a90a79ea
spl set id: ad4fdeec-27f6-33cf-e053-2995a90a1519

Reported adverse events (FAERS/openFDA)#

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