Label: NATURAL FIBER POWDER SMOOTH TEXTURE- psyllium husk granule
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-3026-1 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0224-1852
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 24, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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.
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INDICATIONS & USAGE
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 INGREDIENT
- QUESTIONS
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NATURAL FIBER POWDER SMOOTH TEXTURE
psyllium husk granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3026(NDC:0224-1852) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-3026-1 538 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part334 03/31/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel