FDA.reportPublic FDA data

Senna Tabs

Manufacturer
ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:22

Label at a glance#

ProductSenna Tabs
Active ingredientSENNOSIDES A AND B
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 recommended dose Age Starting Dose Maximum Dose adults and children 12 years of age and older 2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor 4 tablets twice a day, in the morning and at bedtime children under 12 years ask a doctor ask a doctor

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing each tablet contains: calcium 20 mg, potassium 70 mg store at room temperature 

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6mg

Purpose

OTC - PURPOSE SECTION

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

OTC - DO NOT USE SECTION

for more than one week unless directed by a doctor

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have no bowel movement within 12 hours
  • you have rectal bleeding

These could be signs of a serious condition

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • each tablet contains: calcium 20 mg, potassium 70 mg
  • store at room temperature 

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN3
312935sennosides, USP 8.6 MG Oral TabletSCD3
312935sennosides A and B 8.6 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0363-12026-01-29C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-22026-01-29C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-12024-05-09C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-22024-05-09C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-12024-01-30C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-22024-01-30C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-12022-09-22C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-22022-09-22C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-12022-01-28C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts
17856-0363-22022-01-28C16284748780-1d6a99b39-e671-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0363-1Senna Tabs100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1003
17856-0363-2Senna Tabs100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1003
17856-0363-3Senna Tabs1 in 1 POUCHTABLET, FILM COATED13
17856-0363-4Senna Tabs1 in 1 POUCHTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0363SENNA TABS (SENNA) TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]3Legacy NDC, 4 package rows20240511_cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-363-08EA - Each16103-363d1c46bcd-5c41-4cf5-a0d1-def0b83c46da12012-07-24
16103-363-11EA - Each16103-36352f694b3-25f1-401c-a42d-b8750a77e2a612012-07-24

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
17856-036317856-0363-3, 17856-0363-1, 17856-0363-4, 17856-0363-2
16103-363

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
SENNOSIDES A AND B1B5FPI42ENACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT

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 TabsSENNAPharbest Pharmaceuticals, Inc.b9f8ea59-932f-4827-a87c-b4aff909c43f2025-12-24WarningsExact identifier
ndc (product): 16103-363
c1e27c0b-f9bb-4047-a0ea-6585bde60784cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe2024-05-09WarningsExact identifier
spl id: c1e27c0b-f9bb-4047-a0ea-6585bde60784
spl set id: cd6e3fb4-0c5a-4aa7-89ea-109c6d072efe

Reported adverse events (FAERS/openFDA)#

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