KONSYL SUGAR FREE ORANGE WITH STEVIA- psyllium husk powder 
Konsyl Pharmaceuticals, Inc.

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.

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Konsyl Sugar free Orange With Stevia

Drug Facts

Active Ingredient (in each teaspoon)

Psyllium Hydrophilic Mucilloid 3.5g

Purpose

Laxative

Use

For relief of occasional constipation and aid in regularity. This product generally produces bowel movements 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 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

Inactive Ingredients

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

Questions or Comments?

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

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

Label2

Package Labeling: 0224-1884-82

Label 08

KONSYL SUGAR FREE ORANGE WITH STEVIA 
psyllium husk powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1884
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.5 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1884-8177 in 1 CARTON10/01/201806/01/2024
15.8 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:0224-1884-8230 in 1 CARTON10/01/201808/01/2022
25.8 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/201806/01/2024
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Revised: 12/2021
Document Id: d4558e44-9e24-bdc8-e053-2a95a90af1ef
Set id: 0effa2f8-b1ee-4963-a2aa-20832703fc4e
Version: 3
Effective Time: 20211229
 
Konsyl Pharmaceuticals, Inc.