Senna

Manufacturer
LLC Federal Solutions | Safecor Health, LLC
Effective date
2012-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:01

Label at a glance#

ProductSenna
Active ingredientSennosides A and B
Label structure16 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each teaspoonful)
Sennosides 8.8 mg

OTC - PURPOSE SECTION

Purpose
Laxative

INDICATIONS & USAGE SECTION

Uses
relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • Noticed a sudden change in bowel movements that continues over a period of 2 weeks

Do not use laxative products for longer than 1 week unless directed by a doctor

OTC - ASK DOCTOR/PHARMACIST SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

agestarting dosemaximum dosage
adults and children 12 years and older2 - 3 teaspoons once a day3 teaspoons twice a day
children 6 to under 12 years1 - 1 1/2 teaspoons once a day1 1/2 teaspoons twice a day
children 2 to under 6 years1/2 - 3/4 teaspoon once a day3/4 teaspoon twice a day
children under 2 yearsask a doctorask a doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients
cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

OTC - QUESTIONS SECTION

Questions? Call 1-855-333-6337
To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

SPL UNCLASSIFIED SECTION

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-289-05
SENNA SYRUP
(STANDARDIZED EXTRACT OF SENNA FRUIT)
DELIVERS 5 mL
CONTAINING:
SENNOSIDES 8.8 mg
ALCOHOL FREE
NATURAL CHOCOLATE FLAVOR
SHAKE WELL
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132
product labelproduct label

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6289-09ML - Milliliter0904-6289243da47c-1a51-4373-8b52-93808b142f0112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sennosides A and BACTIVE INGREDIENT1B5FPI42EN1
Sennosides A and BACTIVE MOIETY1B5FPI42EN1
COCOAINACTIVE INGREDIENTD9108TZ9KG1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SUCROSEINACTIVE INGREDIENTC151H8M5541
WATERINACTIVE INGREDIENT059QF0KO0R1

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
24451-28924451-289-05, 24451-289-10
0904-6289

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 277 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION/ DROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
COCOACOCOAD9108TZ9KGSUSPENSION / ORAL246.66 mg/5mlExact identifier — unii candidate
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates

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
15ecc7ae-011e-421f-b315-c6dee70bda0fcd5c6f7c-a658-47ef-9626-eb35cd3f10b62012-08-12WarningsExact identifier
spl id: 15ecc7ae-011e-421f-b315-c6dee70bda0f
spl set id: cd5c6f7c-a658-47ef-9626-eb35cd3f10b6

Reported adverse events (FAERS/openFDA)#

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