Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

KONSYL ORANGE EXTRA STRENGTH FORMULA

Dosage form: granule
Ingredients: PSYLLIUM HUSK 6g in 9g
Labeler: Konsyl Pharmaceuticals, Inc.
NDC Code: 0224-1878

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

KONSYL ORANGE EXTRA STRENGTH FORMULA

KONSYL ORANGE EXTRA STRENGTH FORMULA

Active Ingredient (in each tablespoon)

Psyllium Hydrophilic Mucilloid 6 g

Purpose

Laxative

Uses

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

Warnings

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

Stop use and ask a doctor if
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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 olderone tablespoon 1 to 3 times daily
children 6 to under 12 years of age1/2 tablespoon 1 to 3 times daily
children under 6 years of ageconsult a doctor.

Other Information
  • each 9.0g dose contains Potassium 50mg
  • 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 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

Aspartame, citric acid, FD and C Yellow No.6, Maltodextrin, natural and artificial orange flavor, Silicon Dioxide

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

Representative Labeling

KONSYL ORANGE EXTRA STRENGTH FORMULA 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1878
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK6 g  in 9 g
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
CITRIC ACID ACETATE 
SILICON DIOXIDE 
ASPARTAME 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0224-1878-07405 g in 1 CANISTER
2NDC:0224-1878-80405 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/24/2015
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIOperations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-1878)

Revised: 02/2015
 
Konsyl Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide