FDA Label for Natural Fiber Powder Smooth Texture
View Indications, Usage & Precautions
Natural Fiber Powder Smooth Texture Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, 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.
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
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)
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