Label: NATURAL ORANGE FLAVOR ORGANIC NATURAL FIBER- psyllium husk powder

  • NDC Code(s): 68163-571-72
  • Packager: Raritan Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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

  • Active ingredient (in each TABLESPOON)

    Psyllium Hydrophilic Mucilloid 3.4g

  • Purpose

    Fiber therapy for regularity

  • 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 allergic reaction in people sensitive to inhaled or ingested psyllium.

    Ask a doctor before use if you have

    a sudden change in bowel habits persisting for 2 weeks.
    abdominal pain, nausea or vomiting

    Stop use and ask a doctor

    constipation lasts more than 7 days
    rectal bleeding occurs

    These may be sings of a serious condition

    Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • 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 thickness, add more liquid and stir.

    Adults 12 years & older: 1 rounded TABLESPOON in 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 yrs: 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 2 hours after the prescribed medicine. As your body adjusts to increase 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 tablespoon 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.

    TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Questions or comments?

    1-866-467-2748

  • Inactive ingredients

    Natural citric acid, natural flavors, Organic Brown Cane Sugar, Organic Vegetable Glycerin.

  • Principal Display Panel

    NDC 68163-571-72

    NuSyllium

    Natural Orange Flavor

    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 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*.

    No Artificial Flavors, Peanut-free

    No Artificial Colors, Tree Nut-free

    GMO-free, Preservative-free

    Gluten-free, Zero Trans Fat

    Diary-free

    NET WT 30.5 OZ (864 g) 72 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

    Nusyllium Organic Natural Fiber Orange Flavor
  • INGREDIENTS AND APPEARANCE
    NATURAL ORANGE FLAVOR  ORGANIC NATURAL FIBER
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-571
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGE (Natural) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-571-72864 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 DrugM00703/20/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)