FDA.reportPublic FDA data

Senna Plus

Manufacturer
Rebel Distributors Corp
Effective date
2011-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:26

Label at a glance#

ProductSenna Plus
Active ingredientSENNOSIDES A AND B
Label structure8 sections

Indications and uses

For the short term relief of constipation. Produces bowel movement in 6 to 12 hours.

Dosage and administration

° 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 table (do not exceed the maximum dosage) or decrease dose until you are comfortable. Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day) Children 6 to under 12 years : 1 tablet once a day (maximum dosage, 2 tablets twice a day) C...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg

Purpose

OTC - PURPOSE SECTION

Laxative & Stool Softener

Uses

INDICATIONS & USAGE SECTION

For the short term relief of constipation. Produces bowel movement in 6 to 12 hours.

Warnings

WARNINGS SECTION

Do not use ° for longer than one week ° when abdominal pain, nausea or vomiting are present.

Ask a doctor or pharmacist before use if you have noticed a sudden change in bowel habits that lasts over a period of two weeks.

Stop use and ask a doctor if ° you have rectal bleeding ° you fail to have a bowel movement after use of this product, this may indicate a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

° 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 table (do not exceed the maximum dosage) or decrease dose until you are comfortable.

Adults & children over 12 years: 2 tablets once a day (maximum dosage, 4 tablets twice a day)

Children 6 to under 12 years: 1 tablet once a day (maximum dosage, 2 tablets twice a day)

Children 2 to under 6 years: 1.2 tablet once a day (maximum dosage, 1 tablet twice a day)

Children under 2 years: do not use

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature, USP.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow No. 5, FD&C Yellow No. 6, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Sodium Benzoate, Starch, Stearic Acid and Titanium Dioxide.

Distributed by: Plus Pharma

Commack, NY 11725

Repackaged by: Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senna 8.6mgSenna 8.6mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN1
312935sennosides, USP 8.6 MG Oral TabletSCD1
312935sennosides A and B 8.6 MG Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-722-002019-09-24C16284748780-1934fe258-496e-48b1-e053-8cdaa90a720aSenna Plus Drug Facts
21695-722-602019-09-24C16284748780-1934fe258-496e-48b1-e053-8cdaa90a720aSenna Plus Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-722-00Senna Plus100 in 1 BOTTLETABLET1001
21695-722-60Senna Plus60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-722SENNA PLUS TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20111227_5b17afd8-de62-4684-b556-d2846eb214b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-722-00EA - Each21695-722cd4fe7ab-7fdf-497b-be8e-cc3f6569814a12012-07-24
51645-851-10EA - Each51645-851ec774260-08e4-4076-8a87-d96c3a92902412021-11-09
51645-851-99EA - Each51645-8518f93eb26-17ef-46d5-b2d2-63cd91fa3c7a12016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42EN1
SENNOSIDESACTIVE MOIETY3FYP5M0IJX1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-72221695-722-60, 21695-722-00
51645-851

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
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
5b17afd8-de62-4684-b556-d2846eb214b85b17afd8-de62-4684-b556-d2846eb214b82011-09-07WarningsExact identifier
spl id: 5b17afd8-de62-4684-b556-d2846eb214b8
spl set id: 5b17afd8-de62-4684-b556-d2846eb214b8

Reported adverse events (FAERS/openFDA)#

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