Label: KONSYL ORANGE FLAVOR PSYLLIUM FIBER - SMOOTH TEXTURE- psyllium husk granule
- NDC Code(s): 0224-1852-06, 0224-1852-13, 0224-1852-80, 0224-1852-81
- Packager: Konsyl Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 29, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- KONSYL Orange Flavor Psyllium Fiber - Smooth Texture
- Active Ingredient (in each tablespoon)
- Uses
-
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
-
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 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
- each tablespoon contains Potassium 25mg, Sodium 5mg
- 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
- each tablespoon contains Potassium 25mg, Sodium 5mg
- Inactive Ingredients
- Questions or Comments?
- Representative Labeling
- Package Labeling: 0224-1852-80
- Package Labeling: 0224-1852-81
-
INGREDIENTS AND APPEARANCE
KONSYL ORANGE FLAVOR PSYLLIUM FIBER - SMOOTH TEXTURE
psyllium husk granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1852 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 12 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0224-1852-06 538 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 04/01/2020 2 NDC:0224-1852-80 538 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 05/01/2024 3 NDC:0224-1852-81 30 in 1 BOX 03/31/2011 08/01/2022 3 12 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0224-1852-13 30 in 1 BOX 03/31/2011 01/01/2020 4 12 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/31/2011 05/01/2024 Labeler - Konsyl Pharmaceuticals, Inc. (102463866) Registrant - Konsyl Pharmaceuticals, Inc. (102463866)
