FDA.reportPublic FDA data

Senna

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:59:52

Label at a glance#

ProductSenna
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally causes bowel movment in 6 to 12 hours

Dosage and administration

shake well before use Do not exceed recommended dose Age Starting Dose  Maximum dosage  Adults and children 12 years and older  2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime Under 12 years of age  ask a doctor  ask a doctor Other information store at room temperature 20° to 25°C (68° to 77°F). a brown, natur...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

(per teaspoonful - 5 mL)

Sennosides - 8.8 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally causes bowel movment in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden changed in bowel movement that continues over a period of 2 weeks

Stop use and ask a doctor if

you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.

If pregnant or breast-feeding

PREGNANCY SECTION

 ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • Do not exceed recommended dose
AgeStarting Dose Maximum dosage
 Adults and children 12 years and older 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoons in the morning and 3 teaspoons at bedtime
Under 12 years of age ask a doctor ask a doctor

Other information

  • store at room temperature 20° to 25°C (68° to 77°F).
  • a brown, natural flavored syrup supplied in the following oral dosage form:

NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

 citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.

Questions or comments?

OTC - QUESTIONS SECTION

 1-800-845-8210

Distributed By:

SPL UNCLASSIFIED SECTION

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0121-4967-05

Senna Syrup

8.8 mg Sennosides/5 mL

Natural Vegetable Laxative

Package Not Child-Resistant

Pharmacutical Associates, Inc.
Greenville, SC 29605

SEE DRUG FACTS

image description
image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702311sennosides 8.8 MG in 5 mL Oral SolutionPSN7
702311sennosides, USP 1.76 MG/ML Oral SolutionSCD7
702311sennosides 8.8 MG per 5 mL Oral SyrupSY7
702311sennosides, USP 26.4 MG per 15 ML Oral SolutionSY7
702311sennosides, USP 8.8 MG per 5 ML Oral SolutionSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-4967-05Senna5 mL in 1 CUP, UNIT-DOSELIQUID57
0121-4967-40Senna10 in 1 TRAYLIQUID107
0121-4967-40Senna4 in 1 CASELIQUID47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-4967SENNA (SENNOSIDES) LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]7Current NDC, Legacy NDC, 3 package rows20250429_7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4967-05ML - Milliliter0121-4967967b07b3-40f5-45ac-891a-3431f314666012022-04-06
0121-4967-40ML - Milliliter0121-4967772566ca-c6fd-45fe-bcca-75122be4955d12022-04-06

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
0121-49670121-4967-05, 0121-4967-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
CITRIC ACID ACETATEDSO12WL7AUIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT

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
SennaSENNOSIDESPAI Holdings, LLC dba PAI Pharma7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed2025-04-28WarningsExact identifier
ndc (package): 0121-4967-05
ndc (package): 0121-4967-40
ndc (product): 0121-4967
ndc11 (package): 00121496705
ndc11 (package): 00121496740
spl id: 788bfeed-afae-42ae-a24b-0634f35f000b
spl set id: 7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed

Reported adverse events (FAERS/openFDA)#

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