NDC | 0224-1801-06, 0224-1801-07, 0224-1801-35, 0224-1801-80, 0224-1801-81, 0224-1801-84 |
Set ID | 6c876cf1-c2ab-4bdc-bb3e-ac2ce5863649 |
Category | HUMAN OTC DRUG LABEL |
Packager | Konsyl Pharmaceuticals, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART334 |
- Konsyl Original Formula Psyllium Fiber
- Active Ingredients (in each teaspoon)
- 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
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Other Information
- each 6g dose contains: Potassium 50mg
- laxatives, including bulk fibers, may affect how other 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
- Questions or comments?
- Package Labeling
- Package Labeling: 0224-1801-80
- Package Labeling: 0224-1801-84
- Package Labeling: 0224-1801-88
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INGREDIENTS AND APPEARANCE
KONSYL ORIGINAL FORMULA PSYLLIUM FIBER
psyllium husk granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1801 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 6 g in 6 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0224-1801-84 30 in 1 BOX 03/31/2011 1 6 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0224-1801-35 30 in 1 BOX 03/31/2011 03/01/2020 2 6 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0224-1801-07 450 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 04/01/2020 4 NDC:0224-1801-81 450 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 5 NDC:0224-1801-06 300 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 04/01/2020 6 NDC:0224-1801-80 300 g in 1 CANISTER; Type 0: Not a Combination Product 03/31/2011 7 NDC:0224-1801-88 402 g in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/31/2011 Labeler - Konsyl Pharmaceuticals, Inc. (102463866) Registrant - Konsyl Pharmaceuticals, Inc. (102463866)