Senna laxative

Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:53

Label at a glance#

ProductSenna laxative
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 6- 12 hours.

Dosage and administration

take preferably at bedtime or as directed by a doctor age starting dosage  maximum dosage  adults and children 12 years of age and over  2 tablets once a day  4 tablets twice a day  children 6 to under 12 years  1 tablet once a day  2 tablets twice a day  children 2 to under 6 years  1/2 tablet once a day  1 tablet twice a day  children under 2 years  ask a doctor  ask a doctor 

Storage and handling

each tablet contains: calcium 25 mg store at 25 o C (77 o F); excursions permitted between 15 _ 30 o C (59 _ 86 o F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6- 12 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before using if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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

  • take preferably at bedtime or as directed by a doctor
agestarting dosage maximum dosage 
adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day 
children 6 to under 12 years 1 tablet once a day 2 tablets twice a day 
children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day 
children under 2 years ask a doctor ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 25 mg
  • store at 25o C (77o F); excursions permitted between 15_30oC (59_86oF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol, silicon dioxide*, stearic acid*, talc

Questions or comments?

OTC - QUESTIONS SECTION

Call free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Senokot®

Natural Laxative

Sennosides, 8.6 mg

Laxative

Natural Vegetable laxative ingredient

gentle, overnight relief

Tablets

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural Laxative Sennosides Brown Tablet
Natural Laxative Sennosides Brown Tablet

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63548-0486-12023-02-09C16284748780-1f386c649-f200-0266-e053-dadaa90a7c1aDrug Facts
63548-0486-12023-01-30C16284748780-1f386c649-f200-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63548-048663548-0486-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e9bcc787-4fd6-4859-af6f-bb95f866990851db7d70-c0d8-459c-b78f-59409ce536e72023-02-09WarningsExact identifier
spl id: e9bcc787-4fd6-4859-af6f-bb95f8669908
spl set id: 51db7d70-c0d8-459c-b78f-59409ce536e7

Reported adverse events (FAERS/openFDA)#

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