Natural Fiber Powder Smooth Texture

Dosage form: granule
Ingredients: PSYLLIUM HUSK 3.4g in 100g
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-3026

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.

Active ingredient (in each dose)

Psyllium Hydrophilic Mucilloid 3.4 grams

 Purpose

Bulk-Forming Laxative

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

Warnings  Allergy alert Inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to psyllium. Choking  Taking this product without adequate fluid may cause it ot 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:  sprinkle one dose, 1 rounded tablespoonful (12g), 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 12 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 seal is broken or missing - laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines. - can be taken 1 to 3 times daily, before or after meals, mornings, or evenings - maximum daily dose (3 tablespoonfuls) is very low sodium - do not discard Konsyl Orange powder into any plumbing systems  - note to diabetics: this product contains 66% sugar (sucrose) - each dose provides 3 grams total dietary fiber - each dose contains 35 calories

Inactive ingredients  citric acid, D and C yellow No. 10 and FD and C Yellow No.6 (Sunset Yellow), flavoring, sucrose.


Questions? Call  Konsyl Pharmaceuticals, Inc. at 1-800-36-6795 8:30 a.m to 5 p.m. ET.

When using this product physicians recommend a gradual increase in dietary fiber.  If minor gas or bloating occurs, begin with a 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.  33792 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 THIS 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 45  Amount Per Serving %DV* Calories (Available) 35  Sodium 0%  Carbohydrates (Available) 8g 3% Dietary Fiber 3g 11% Soluble Fiber 2g - Sugars 8g - Calcium 0%  Iron 6%  *Percent Daily Values (DV) are based on a 2,000 calorie diet.  - Daily Value (DV) not established.

Psyllium Hydrophilic Mucilloid  Smooth Texture  Gluten Free  Helps Lower Cholesterol NET WEIGHT 12.0g   K PAREVE  SUPPLEMENTS / LAXATIVE  TAMPER-EVIDENT PACKAGE. DO NOT USE IF OPENED OR DAMAGED.  DIRECTIONS FOR USE:  MIX THIS PRODUCT (CHILD OF 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 WARNINGS. 1. Sprinkle one packet into a shaker or glass containing 8 oz. of cool water. 2 Cover. Shake well for 3-5 seconds, or stir well. 3. Drink promptly. If mixture thickens, add more liquid and stir.  Follow with additional liquid to aid product action.  DOSAGE: Adults and children 12 years of age and over:  One packet (or dose) 1 to 3 times daily, before or after meals, or as directed by a doctor. Children 6 to under 12 years of age: 1/2 adult dose, or as directed by a doctor. Children under 6 years of age: Consult a doctor.  INDICATIONS: For relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.  See insert or carton for complete WARNINGS.  ALLERGY ALERT: Inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to psyllium.

Manufactured by Konsyl Pharmaceuticals, Inc. Easton, MD 21601 Store below 86 Degree F (30 Degree Centigrade) 3 02241 85200 5



Additional barcode labeling by:  Physicians Total Care, Inc., Tulsa, Oklahoma  74146

NDC 54868-3026-1 

Natural Fiber Smooth Texture Powder

Psyllium Hydrophilic Mucilloid  Heart Healthy  Smooth Texture 

Gluten Free Helps Lower Cholesterol 

K PAREVE Naturally Sweetened SUPPLEMENTS / LAXATIVE

NET WEIGHT 538 (19oz)

(FILL CONTROLLED BY WEIGHT NOT VOLUME)

NATURAL FIBER POWDER  SMOOTH TEXTURE
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3026(NDC:0224-1852)
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
CITRIC ACID MONOHYDRATE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
SUCROSE 
Packaging
#Item CodePackage Description
1NDC:54868-3026-1538 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33403/31/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 01/2012
 
Physicians Total Care, 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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