FDA Label for Konsyl Sugar Free Orange With Stevia

View Indications, Usage & Precautions

Konsyl Sugar Free Orange With Stevia Product Label

The following document was submitted to the FDA by the labeler of this product Konsyl Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



  • 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



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)




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