Label: UNFLAVORED ORGANIC NATURAL FIBER- psyllium husk powder
- NDC Code(s): 68163-570-85
- Packager: Raritan Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated September 17, 2020
If you are a consumer or patient please visit this version.
- Active ingredient
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.
Allergy alert: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.
Put one dose into an empty glass. 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 warning. Stir briskly and drink promptly.
If mixture thickens, add more liquid.
Adults 12 Years and older: 1 rounded TEASPOON into an 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.
Children under 12 years: Consult a doctor before use.
Bulk-forming fibers like Psyllium husk may affect how well other medicines work, If you are taking a prescription medicine by mouth, take this product at least 2 hours before or after the prescribed medicine.
As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
Start with 1 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake.
- each teaspoon contains: potassium 35 mg; sodium 5 mg
- store at room temperature tightly closed to protect from humidity
- do not use if printed seal under cap is torn or missing
- contains a 100% natural, therapeutic fiber
‡Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from fiber such as NuSyllium may reduce the risk of heart disease by lowering cholesterol.
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
ALLERGY ALERT: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.
- Inactive ingredients
Principal Display Panel
Unflavored Organic Natural Fiber
100% Organic Certified Psyllium
Perfect Grind For Easy Mixing™
NO ARTIFICIAL INGREDIENTS
100% Natural Fiber Supplement
Fiber Laxative for Regularity
Made with 100% Organic Brown Cane Sugar
Folks are taking about the Benefits of NuSyllium Ultra Organic Natural Fiber!
- You can use NuSyllium to feel less hungry between meals.
- Maintain healthy blood sugar levels by using NuSyllium Ultra as part of your sugar free diet*. Talk to your doctor before use if you are taking medication to control your blood sugar levels.
- Organic NuSyllium is a great choice for promoting and maintain digestive health. You can use NuSyllium Ultra for occasional constipation and to help promote and maintain regularity.
- Did you know that one dose of NuSyllium Ultra contains 2 gm. of soluble fiber? You can use it for lowering cholesterol and promoting heart health*.
- Talk to your doctor who will have good advice for you to use NuSyllium Ultra as part of your cholesterol –lowering program.
No Artificial Flavors, Peanut-free
No Artificial Colors, Tree Nut-free
Gluten-free, Zero Trans Fat
Diary-free, No animal testing
NET WT 21 OZ (595 g) 85 DOSES
Fill controlled by weight, not volume
Made in the U.S.A. with domestic and foreign components.
Distributed by: Lifelab Health LLC
6574 N.State Road #7 361
Coconut Creek, FL 33073, No animal testing
INGREDIENTS AND APPEARANCE
UNFLAVORED ORGANIC NATURAL FIBER
psyllium husk powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68163-570 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 7 g Inactive Ingredients Ingredient Name Strength RAW SUGAR (UNII: 8M707QY5GH) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68163-570-85 595 g in 1 CANISTER; Type 0: Not a Combination Product 03/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/20/2019 Labeler - Raritan Pharmaceuticals Inc (127602287)