Konsyl Naturally Sweetened Psyllium Fiber

Dosage form: granule
Ingredients: PSYLLIUM HUSK 3.4g in 100g
Labeler: Konsyl Pharmaceuticals, Inc.
NDC Code: 0224-1822

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.

Konsyl Naturally Sweetened Psyllium Fiber

Active ingredient (in each dose)                

Psyllium Hydrophilic Mucilloid 3.4 grams

Purpose
Bulk-Forming Laxative

Use For relief of occasional costipation. Generally produces effect in 12-72 hours. Natural bulk producing fiber encourages normal elimination without chemical stimulants.

Warnings  Allergy alert Inhaled or ingested psullium powder may cause an allergic reaction in people sensitive to psyllium.  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 laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have  - a sudden change in bowel habits that persists over a period of two weeks

When using this product  - do not take for a period longer than 1 week, unless directed by a doctor

Stop use and ask a doctor if  - you experience rectal bleeding  -  you fail to have a bowel movement

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 (child or adult dose)  with at least 8 ounces (a full glass) of water or other fluid.  Taking this product without enough liquid may cause choking.  See choking warnings.

adults and children 12 years and over 1 rounded teaspoonful (6.5g) mixed in 8 oz of liquid, 1-3 times daily
children 6 years to under 12 years
1/2 the adult dose in 8 oz of liquid, up to 3 times daily.
children under 6 years
Consult a doctor.

Other information  - each 6.5 g dose contains: Calcium  6 mg, Potassium 31 mg.  Sodium 3 mg - store below 86 degree F (30 Degree Centigrade)  - keep container tightly closed - protect from excessive moisture - tamper-evident bottle mouth sealed for your protection - do not use if imprinted inner sela is broken or missing - laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines - see label for expiration date - can be taken 1 to 3 times daily, before or after meals, mornings, or evenings - maximum daily dose (3 teaspoonful) is very low sodium - do not discard powder into any plumbing systems - note to diabetics: this product contains 48 % sugar (dextrose) - no starch, no flavors, no color added  - each dose provides 3 grams total dietary fiber - each dose contains 14 calories


Inactive ingredients  dextrose

Questions? Call  Konsyl Pharmaceuticals, Inc, at 1-800-356-6795 8:30 a.m to 5 p.m. ET.

When using this product physicians recomend a fradual increase in dietary fiber. If minor fas or bloating occurs, begin with a half-dose and slowly increase the dose over several days.  Always follow with 8 oz. of fluid.  Manufactured by  Konsyl Pharmaceuticals, Inc. Easton, MD 21601 www.konsyl.com  Konsyl Pharmaceuticals, Inc.  33786 0810  Dietary Fiber Supplement  Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium hust may reduce the risk of Coronary Heart Disease (CHD) by lowering cholesterol.  ONE ADULT DOSE OF THIS PRODUCT CONTAINS 2.0 GRAMS PF THOS SOLUBLE FIBER = 3.4 G OF PSYLLIUM  Dosage  Adults 12 years and older: 1 Rounded teaspoonful in 8 oz. of fluid 2 TIMES DAILY, follow with additional fluid to aid product action, before or after meals, mornings or evenings.   Children under 12 years: Consult a doctor.  Notice Ask a doctor before use if you consider taking this product as part of a cholesterol-lowering program.  See directions for use before taking this product.  Supplements Facts  Serving size (dose): 1 rounded  teaspoonful psyllium  3.4g  Serving per container 77  Amount Per Serving %DV* Calories (Available) 14  Sodium 0%  Carbohydrates (Available) 3g 1% Dietary Fiber 3g 11% Soluble Fiber 2g - Sugars 3g - Calcium 0%  Iron 6%  *Percent Daily Values (DV) are based on a 2,000 calorie diet.  - Daily Value (DV) not established.

NDC 0224-1822-03     KONSYL  NATURALLY  SWEETENED PSYLLIUM FIBER  Psyllium Hydrophilic Mucilloid Heart Healthy Formerly Konsyl-D  Gluten Free  Helps Lower Cholesterol  SUPPLEMENT / LAXATIVE  NET WEIGHT 397 g (14oz) (FILL CONTROLLED BY WEIGHT NOT VOLUME)

NDC 0224-1822-07      KONSYL  NATURALLY  SWEETENED PSYLLIUM FIBER  Psyllium Hydrophilic Mucilloid Heart Healthy Formerly Konsyl-D  Gluten Free  Helps Lower Cholesterol  SUPPLEMENT / LAXATIVE  NET WEIGHT 500g (17.6oz) (FILL CONTROLLED BY WEIGHT NOT VOLUME)

KONSYL NATURALLY SWEETENED PSYLLIUM FIBER 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1822
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
Packaging
#Item CodePackage Description
1NDC:0224-1822-03397 g in 1 CANISTER
2NDC:0224-1822-07500 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33403/31/2011
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIOperations
Konsyl Pharmaceuticals, Inc.102463866manufacture

Revised: 03/2011
 
Konsyl Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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