Label: KONSYL SUGAR FREE ORANGE WITH STEVIA- psyllium husk powder
- NDC Code(s): 0224-1884-81, 0224-1884-82
- Packager: Konsyl Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 2, 2019
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- Drug Facts
- Active Ingredient (in each teaspoon)
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
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
- each 5.8g dose contains Potassium 35mg
- 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 use discard konsyl inot any plumbing system
- store below 86° F (30° C)
- keep container tightly closed-protect from excessive moisture
- can be taken before or after meals, mornings or eveings
- Inactive Ingredients
- Questions or Comments?
- Konsyl Sugar free Orange With Stevia, 450g (0224-1884-81)
- Package Labeling: 0224-1884-82
INGREDIENTS AND APPEARANCE
KONSYL SUGAR FREE ORANGE WITH STEVIA
psyllium husk powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1884 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.5 g in 5.8 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0224-1884-81 77 in 1 CARTON 10/01/2018 1 5.8 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:0224-1884-82 30 in 1 CARTON 10/01/2018 2 5.8 g in 1 PACKAGE; 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 10/01/2018 Labeler - Konsyl Pharmaceuticals, Inc. (102463866)