KONSYL SUGAR FREE ORANGE FLAVOR PSYLLIUM FIBER  - psyllium husk granule 
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 Flavor Psyllium Fiber


Active Ingredient (in each teaspoon)

Psyllium Hydrophylic Mucilloid 3.5.g

Purpose

Laxative

Uses

For relief of occasional constipation and to induce 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 movements, 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 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 5.8g dose contains: Potassium 25mg
  • Phenylketonurics : Contains phenylalanine, 21 mg per teaspoon
  • 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 degree F (30 degree C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or evenings

Inactive Ingredients

Aspartame, Citric Acid, FDandC Yellow No. 6, Maltodextrin, Natural and Artificial Orange Flavor, Silicon Dioxide.

Questions or Comments?

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


* For lowering cholesterol to promote heart health.

Diets low in saturated fact and cholesterol that include 7 grams of soluble fiber per day from psyllium husk as in Konsyl Orange Sugar-Free may reduce the risk of heart disease by lowering cholesterol. One adult dose of Konsyl Orange Sugar-Free has 2 grams of this soluble fiber.

Supplement Facts

Serving Size: 1 teaspoon (5.8g)
Servings Per Container 49

Amount Per Serving                            % Daily Value
Calories 20
Total Carbohydrate 5g                                 2%*
Dietary Fiber 3g                                         14%*
Soluble Fiber 2g                                               +
Insoluble Fiber less than 1g                               +

* Percent Daily Values are based on a 2,000 calorie diet. + Daily Value not established.

Ingredients: Psyllium Hydrophylic Mucilloid (husks), Maltodextrin, Citric Acid, Natural and Artidicial Flavor, Silicon Dioxide, Aspartame, FDandC Yellow No. 6

PHENYLKETONURICS: Contains Phenylalanine
Manufactured By
Konsyl Pharmaceuticals, Inc.
Easton, MD 21601
www.konsyl.com
c Konsyl Pharmaceuticals, Inc.


Dosage: Adults and children 12 years and over: One teaspoon 1 to 3 times daily. Children 6 to under 12 years of age: 1/2 teaspoon 1 to 3 times daily. Follow with additional fluid to aid product action, before or after meals, mornings or evenings.
Children under 6 years of age: consult a doctor. Notice: This product should be taken with at least a full glass of liquid. 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. Warnings: Read entire label, including warnings in Drug Facts. Allergy Alert: Inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to psyllium.

N3  0224 - 1866 - 28 6

NDC 0224-1866-28

KONSYL ORANGE FLAVOR
naturally and artificially flavored
PSYLLIUM FIBER
LAXATIVE / SUPPLEMENT

For relief of occasional constipation and irregularity

Smooth Texture

Gluten Free

Helps Lower Cholesterol To Support Heart Health

Sugar Free

NET WEIGHT 10oz (283g)

KONSYL Sugar Free Orange Flavor Psyllium Fiber 283g (0224-1866-28)

Label

KONSYL SUGAR FREE ORANGE FLAVOR PSYLLIUM FIBER  
psyllium hydrophilic mucilloid granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1866
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
SILICON DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:0224-1866-281 in 1 PACKAGE
1283 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/20/2013
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-1866)

Revised: 06/2013
 
Konsyl Pharmaceuticals, Inc.