FDA.reportPublic FDA data

Konsyl Orange Extra Strength Formula

Manufacturer
Konsyl Pharmaceuticals, Inc
Effective date
2018-12-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:44:11

Label at a glance#

ProductKonsyl Orange Extra Strength Formula
Active ingredientPSYLLIUM HUSK
Label structure8 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 tablespoon 1 to 3 times daily  children 6 to under 12 years of age    1/2 tablespoon 1 to 3 times daily  children under 6 years of age  consult a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablespoon)

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 causechoking. 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 tablespoon 1 to 3 times daily
 children 6 to under 12 years of age   1/2 tablespoon 1 to 3 times daily
 children under 6 years of age consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • each 9.0g close contains ​Potassium​ 50mg
  • laxatives, including bulk fibers, may effect how other medicines work, wait 1-2 hours before or after taking other medicine
  • 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 0​ f (30 ​0 ​C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or evenings

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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

LabelLabel

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
0224-18790224-1879-81, 0224-1879-80

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
SILICON DIOXIDEETJ7Z6XBU4IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
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
7c5c6686-687e-5c30-e053-2a91aa0a0f69281d9ad4-8ea0-4d32-aa92-bc826587b6112018-12-06WarningsExact identifier
spl id: 7c5c6686-687e-5c30-e053-2a91aa0a0f69
spl set id: 281d9ad4-8ea0-4d32-aa92-bc826587b611

Reported adverse events (FAERS/openFDA)#

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