Natural Fiber Powder
FDA Label NDC 54868-3026

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Natural Fiber Powder (NDC 54868-3026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each dose)

Psyllium Hydrophilic Mucilloid 3.4 grams

Otc - Purpose

 Purpose

Bulk-Forming Laxative

Indications & Usage

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

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

Warnings

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.

Otc - Do Not Use

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.

Otc - Ask Doctor

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

Otc - When Using

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

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

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.

Inactive Ingredient

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

Otc - Questions

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

Description

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.

Package Label.Principal Display Panel

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 

Image Of Package Label (3026)

Image Of Package Label (3026)

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)

* Please review the disclaimer below.