Senna Laxative

Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2025-05-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:01:21

Label at a glance#

ProductSenna Laxative
Active ingredientSENNOSIDES A AND B
Label structure10 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 is broken or missing from bottle. 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 is broken or missing from bottle.
  • 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

16 HOW SUPPLIED

HOW SUPPLIED SECTION

Senna Laxative Tablets are available as follows:

8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

10 tablets (NDC 43063-838-10)

30 tablets (NDC 43063-838-30)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

43063838 Label
43063838 Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN9
312935sennosides, USP 8.6 MG Oral TabletSCD9
312935sennosides A and B 8.6 MG Oral TabletSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-838-10Senna Laxative10 in 1 BOTTLE, PLASTICTABLET, FILM COATED109
43063-838-30Senna Laxative30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-838SENNA LAXATIVE (SENNA) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20250523_2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-838-10EA - Each43063-838502d4cdb-27f1-4792-a13c-d40c11fd92b612021-04-08
43063-838-30EA - Each43063-8380635c75e-8c2f-4653-aa82-b9305f27878312021-04-08
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
43063-83843063-838-10, 43063-838-30
16103-363

Ingredients#

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

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

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
Senna LaxativeSENNAPD-Rx Pharmaceuticals, Inc.2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa2025-05-21WarningsExact identifier
ndc (package): 43063-838-30
ndc (package): 43063-838-10
ndc (product): 43063-838
ndc11 (package): 43063083830
ndc11 (package): 43063083810
spl id: 35ad18d5-ff70-f8e1-e063-6294a90ae15f
spl set id: 2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa

Reported adverse events (FAERS/openFDA)#

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