FDA.reportPublic FDA data

SENNA-PLUS

Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:51

Label at a glance#

ProductSENNA-PLUS
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours

Dosage and administration

• do not exceed 8 tablets in 24 hours Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor 4 tablets in the morning and 4 tablets at bedtime children under 12 years ask a doctor

Storage and handling

each tablet contains: calcium 20 mg, sodium 3 mg store at controlled room temperature Tamper Evident: Do not use if imprinted seal under cap is missing or broken. product of India

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts over two weeks

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.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed 8 tablets in 24 hours

Age
Starting Dose
Maximum Dose
adults and children 12 years of age and older
2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
4 tablets in the morning and 4 tablets at bedtime
children under 12 years
ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
    Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

HOW SUPPLIED

How Supplied Section

NDC: 71335-1674-1: 30 Tablets in a BOTTLE

NDC: 71335-1674-2: 120 Tablets in a BOTTLE

NDC: 71335-1674-3: 60 Tablets in a BOTTLE

NDC: 71335-1674-4: 90 Tablets in a BOTTLE

NDC: 71335-1674-5: 100 Tablets in a BOTTLE

NDC: 71335-1674-6: 28 Tablets in a BOTTLE

NDC: 71335-1674-7: 56 Tablets in a BOTTLE

NDC: 71335-1674-8: 14 Tablets in a BOTTLE

NDC: 71335-1674-9: 20 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate/ Sennosides 50/8.6 mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1674-1SENNA-PLUS30 in 1 BOTTLETABLET303
71335-1674-2SENNA-PLUS120 in 1 BOTTLETABLET1203
71335-1674-3SENNA-PLUS60 in 1 BOTTLETABLET603
71335-1674-4SENNA-PLUS90 in 1 BOTTLETABLET903
71335-1674-5SENNA-PLUS100 in 1 BOTTLETABLET1003
71335-1674-6SENNA-PLUS28 in 1 BOTTLETABLET283
71335-1674-7SENNA-PLUS56 in 1 BOTTLETABLET563
71335-1674-8SENNA-PLUS14 in 1 BOTTLETABLET143
71335-1674-9SENNA-PLUS20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1674SENNA-PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 9 package rows20240410_7f8396e7-07f0-4c9c-be8a-9dc00139cb83.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1674-2EA - Each71335-167486b018bc-d977-466b-901b-580249d5a13d12022-01-06
71335-1674-3EA - Each71335-1674c6138d0f-b193-47e5-900d-60d8de52bc3412022-03-09
71335-1674-5EA - Each71335-1674a3c81d97-7662-49bc-a1b9-13d1b25f519f12024-02-14
57896-555-01EA - Each57896-55599ff87f3-bd78-44e5-95d2-ced09a47e88712020-08-06
57896-555-06EA - Each57896-555c097fdf8-843e-480e-b2c8-169d6169722112021-12-08
57896-555-10EA - Each57896-555a8f7f135-b3ac-4250-967e-cb39c37b340612020-06-05
57896-555-20EA - Each57896-5552bd72b42-9f99-4221-abc0-be95352cf75212022-03-09

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
71335-167471335-1674-1, 71335-1674-2, 71335-1674-3, 71335-1674-4, 71335-1674-5, 71335-1674-6, 71335-1674-7, 71335-1674-8, 71335-1674-9
57896-555

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENNA-PLUSSENNOSIDES AND DOCUSATE SODIUMGeri-Care Pharmaceutical Corp8a0882ed-f623-2359-e053-2995a90a6f982024-11-28WarningsExact identifier
ndc (product): 57896-555
SENNA-PLUSSENNOSIDES AND DOCUSATE SODIUMBryant Ranch Prepack7f8396e7-07f0-4c9c-be8a-9dc00139cb832024-04-04WarningsExact identifier
ndc (package): 71335-1674-1
ndc (package): 71335-1674-8
ndc (package): 71335-1674-2
ndc (package): 71335-1674-9
ndc (package): 71335-1674-7
ndc (package): 71335-1674-4
ndc (package): 71335-1674-3
ndc (package): 71335-1674-5
ndc (package): 71335-1674-6
ndc (product): 71335-1674
ndc11 (package): 71335167403
ndc11 (package): 71335167409
ndc11 (package): 71335167407
ndc11 (package): 71335167406
ndc11 (package): 71335167401
ndc11 (package): 71335167408
ndc11 (package): 71335167405
ndc11 (package): 71335167402
ndc11 (package): 71335167404
spl id: efcc90d6-8e49-47f4-a370-4bc1156cf742
spl set id: 7f8396e7-07f0-4c9c-be8a-9dc00139cb83

Reported adverse events (FAERS/openFDA)#

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