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.

Drug Label Information

Updated September 17, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Psyllium husk 3.4g (1 rounded teaspoon = 7g)

  • Purpose

    Bulk-forming laxative

  • Use

    For relief of occasional constipation (regularity)

  • Warnings

    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.

  • Directions

    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.

    NEW USERS

    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.

    Keep Out of Reach of Children

  • Other information

    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.

    Questions or comments?

    1-866-467-2748

  • Inactive ingredients

    Organic Brown Cane Sugar, Organic Vegetable Glycerin.

  • Principal Display Panel

    NDC 68163-570-85

    NuSyllium

    Unflavored Organic Natural Fiber

    100% Organic Certified Psyllium

    Perfect Grind For Easy Mixing™

    USDA ORGANIC

    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

    GMO-free, Preservative-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

    Nusyllium Unflavored Organic Natural Fiber
  • INGREDIENTS AND APPEARANCE
    UNFLAVORED ORGANIC NATURAL FIBER 
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-570
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    RAW SUGAR (UNII: 8M707QY5GH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-570-85595 g in 1 CANISTER; Type 0: Not a Combination Product03/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/20/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)