FDA.reportPublic FDA data

SENNA

Manufacturer
Rugby Laboratories
Effective date
2019-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:47:54

Label at a glance#

ProductSENNA
Active ingredientSENNOSIDES
Label structure11 sections

Indications and uses

• Relieves occasional constipation (irregularity), • Generally produces bowel movement in 6-12 hours

Dosage and administration

• take preferably at bedtime or as directed by a doctor.   Age   Starting dose   Maximum dose   Adults and children 12 years and   older   2-3 teaspoons once a day   3 teaspoons twice a day   Children 6 to under 12 years   1 – 1 ½ teaspoons once a day   1 ½ teaspoons twice a day   Children 2 to under 6 years   ½ - ¾ teaspoon once a day   ¾ teaspoon twice a day   Children under 2 years   Ask a doctor   Ask a doctor

Label contents#

Full prescribing information#

SENNA LIQUID

SPL UNCLASSIFIED SECTION

Natural Vegetable

Stimulant Ingredient

Laxative

Active ingredient (in each teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.8 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • Relieves occasional constipation (irregularity),
  • Generally produces bowel movement in 6-12 hours

Warnings

WARNINGS SECTION

Do not use

  • For longer than one week
  • When abdominal pain, nausea or vomiting are present
  • Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks
  • Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
  • Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have bowel movement after use of this product. These may indicate a serious condition.

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

Keep Out of Reach of Children

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

  • take preferably at bedtime or as directed by a doctor.
  • Age
  • Starting dose
  • Maximum dose
  • Adults and children 12 years and
  • older
  • 2-3 teaspoons once a day
  • 3 teaspoons twice a day
  • Children 6 to under 12 years
  • 1 – 1 ½ teaspoons once a day
  • 1 ½ teaspoons twice a day
  • Children 2 to under 6 years
  • ½ - ¾ teaspoon once a day
  • ¾ teaspoon twice a day
  • Children under 2 years
  • Ask a doctor
  • Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Avoid excessive heat
  • Store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions or Comments

SPL UNCLASSIFIED SECTION

Questions or comments

Call 1-800-645-2158

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Compare to Active Ingredient in SENOKOT®*

*Rugby Laboratories is not affiliated with the owner of the trademark Senokot®.

Distributed by: Rugby Laboratories

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Re-order No.: 370559

ION 559L

Rev. 09/18 R-150

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Senna Liquid

Standardized Senna Concentrate

Natural Vegetable

Stimulant Ingredient

8 fl oz (237 mL)

bottle label
bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1138-592021-08-27C16284748780-1ba0f9c33-5e68-a910-e053-dadaa90a0b8525845761-b780-4d53-9db7-3f21bcc51fc2
0536-1138-592021-01-29C16284748780-1ba0f9c33-5e68-a910-e053-dadaa90a0b8525845761-b780-4d53-9db7-3f21bcc51fc2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11380536-1138-59

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
SENNOSIDES3FYP5M0IJXACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SUCROSEC151H8M554IACT
COCOAD9108TZ9KGIACT

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
b985a807-2c57-4da2-b14d-0c9d81f028df25845761-b780-4d53-9db7-3f21bcc51fc22021-08-25WarningsExact identifier
spl set id: 25845761-b780-4d53-9db7-3f21bcc51fc2

Reported adverse events (FAERS/openFDA)#

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