FDA.reportPublic FDA data

Konsyl Sugar free Orange With Stevia

Manufacturer
Konsyl Pharmaceuticals, Inc.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:08

Label at a glance#

ProductKonsyl Sugar free Orange With Stevia
Active ingredientPSYLLIUM HUSK
Label structure9 sections

Dosage and administration

Mix this product with at least 8 ounces (a full glass) of water of 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 Ingredient (in each teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Psyllium Hydrophilic Mucilloid 3.5g

Purpose

OTC - PURPOSE SECTION

Laxative

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation and aid in 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 of 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 5.8g dose contains Potassium 35mg
  • laxatives, including bulk fibers, may affect how 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 use discard konsyl inot any plumbing system
  • store below 86° F (30° C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or eveings

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, FD&C Yellow No.6, Maltodextrin, Natural and Artificial Orange Flavor, Rebaudioside A, Silicon Dioxide.

Questions or Comments?

OTC - QUESTIONS SECTION

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

Konsyl Sugar free Orange With Stevia, 450g (0224-1884-81)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 0224-1884-82

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 08Label 08

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0224-1884-81GM - Gram0224-18840e7ee5d5-7349-4e84-81c1-e48068cc55e512018-12-13
0224-1884-82EA - Each0224-188425c81106-789c-4399-ad68-c13cfb3d3eb812019-04-11

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0224-18840224-1884-81, 0224-1884-82

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MALTODEXTRIN7CVR7L4A2DIACT
REBAUDIOSIDE AB3FUD0528FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PSYLLIUM HUSK0SHO53407GACTIB

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
d4558e44-9e24-bdc8-e053-2a95a90af1ef0effa2f8-b1ee-4963-a2aa-20832703fc4e2021-12-29WarningsExact identifier
spl id: d4558e44-9e24-bdc8-e053-2a95a90af1ef
spl set id: 0effa2f8-b1ee-4963-a2aa-20832703fc4e

Reported adverse events (FAERS/openFDA)#

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