FDA.reportPublic FDA data

KONSYL Original Formula Psyllium Fiber

Manufacturer
Konsyl Pharmaceuticals, Inc.
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
30
Source
full-release
Hydrated at
2026-06-01 00:07:09

Label at a glance#

ProductKONSYL Original Formula Psyllium Fiber
Active ingredientPSYLLIUM HUSK
Label structure11 sections

Indications and uses

For relief of occasional constipation and to induce regularity. This product generally produces bowel movements within 12-72 hours.

Dosage and administration

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning. adults and children 12 years and older |one teaspoon 1 to 3 times daily children 6 to under 12 years of age      | 1/2 teaspoon 1 to 3 times daily children under 6 years of age               | consult a doctor

Label contents#

Full prescribing information#

Active Ingredients (in each teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Psyllium Hydrophilic Mucilloid 6g

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

For relief of occasional constipation and to induce regularity.

This product generally produces bowel movements within 12-72 hours.

Warnings

WARNINGS SECTION

Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Do not use

OTC - DO NOT USE SECTION

  • when abdominal pain, nausea or vomiting are present unless directed by a doctor.
  • if constipation lasts more than seven days
  • if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience rectal bleeding or fail to have a bowel movement, as these may be signs of a serious condition

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

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.

adults and children 12 years and older |one teaspoon 1 to 3 times daily

children 6 to under 12 years of age      | 1/2 teaspoon 1 to 3 times daily

children under 6 years of age               | consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • each 6g dose contains: Potassium 50mg
  • laxatives, including bulk fibers, may affect how other other medicines work, wait 1-2 hours before or after taking other medicines
  • tamper-evident bottle mouth sealed for your protection 
  • do not use if imprinted inner seal is broken or missing
  • do not discard Konsyl into any plumbing system
  • store below 86 degrees F (30 degrees C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or evenings

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

  • 1-800-356-6795  8:30 a.m to 5 p.m. ET.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 2Label 2

Package Labeling: 0224-1801-80

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 01Label 01

Package Labeling: 0224-1801-84

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 02Label 02

Package Labeling: 0224-1801-88

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 03Label 03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0224-1801KONSYL ORIGINAL FORMULA PSYLLIUM FIBER (PSYLLIUM HUSK) GRANULE [KONSYL PHARMACEUTICALS, INC.]30Legacy NDC20240113_6c876cf1-c2ab-4bdc-bb3e-ac2ce5863649.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0224-1801-06GM - Gram0224-1801b359f08d-6c3a-4627-b7b7-36762c067cdf12012-07-24
0224-1801-07GM - Gram0224-1801f60e18ca-4d46-47ee-9a44-a92db09d4ec112012-07-24
0224-1801-35EA - Each0224-180138d2cc7d-948c-485d-9fee-85ec7c17487f12012-07-24
0224-1801-80GM - Gram0224-1801ae15b5a2-270b-4a10-884d-a79d0dab372d12014-05-02
0224-1801-81GM - Gram0224-1801889ad8ab-4f47-4fa2-a29b-7876c2cf6b7312014-05-02
0224-1801-84EA - Each0224-1801cddf8683-a0b2-4d55-b296-a07fac7df06412014-05-02
0224-1801-88GM - Gram0224-180113d6a3a4-f08a-4558-8562-231ffdf8484512018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PSYLLIUM HUSKACTIVE INGREDIENT0SHO53407G8
PSYLLIUM HUSKACTIVE MOIETY0SHO53407G8

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0224-18010224-1801-84, 0224-1801-35, 0224-1801-07, 0224-1801-81, 0224-1801-06, 0224-1801-80, 0224-1801-88

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB

Source Document#

Source XML · Source PDF

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
0ec2ed7d-7d13-dc20-e063-6294a90a93156c876cf1-c2ab-4bdc-bb3e-ac2ce58636492024-01-12WarningsExact identifier
spl id: 0ec2ed7d-7d13-dc20-e063-6294a90a9315
spl set id: 6c876cf1-c2ab-4bdc-bb3e-ac2ce5863649

Reported adverse events (FAERS/openFDA)#

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