ULTRA ORGANIC FIBER SUGAR FREE (PSYLLIUM HUSK) POWDER [RARITAN PHARMACEUTICALS INC]

ULTRA ORGANIC FIBER SUGAR FREE (PSYLLIUM HUSK) POWDER [RARITAN PHARMACEUTICALS INC]
PDF | XML

NDC 68163-575-42
Set ID fcc9a98b-bb35-498a-93ac-666e57df438e
Category HUMAN OTC DRUG LABEL
Packager Raritan Pharmaceuticals Inc
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient

    Psyllium husk 3.4g (per each rounded teaspoon = 7g)

  • Purpose

    Bulk-forming laxative

  • Use

    effective in treating occasional constipation and restoring regularity

  • Warnings

    Allergy alert:This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.

  • Directions

    Adults 12 Years and older (up to 3 times daily): Put 1 rounded TEASPOON into an empty glass. Mix this product with at least 8 oz (a full glass) of water.

    Stir briskly to mix the fiber into the water fully and drink promptly. Taking without enough water may cause choking. Do not take this product if you have difficulty following.

    As bulk-forming fibers such as NuSyllium Ultra may affect how medicines work, take this product at least 2 hours before or after taking your medicine,

    You can take NuSyllium Ultra at any time of the day. Children under 12 years: Consult a doctor before use.

    Stop using a NuSyllium and see a doctor if constipation lasts more than a week or if rectal bleeding occurs as these may be signs of a serious condition.

    FIRST-TIME USERS

    Start with one serving per day and then adjust your dose upwards as needed. Adding fiber to your diet may cause changes in your bowel habits or minor bloating.

    These are normal reactions as your body adjusts to the increase fiber in your diet.

    Keep Out of Reach of Children

  • Other information

    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.

    Questions or comments?

    1-866-467-2748

  • Inactive ingredients

    Natural Citric Acid, Natural Flavors, Natural Stevia Extract, Organic Glycerin.

  • Principal Display Panel

    NDC 68163-575-42

    NuSyllium

    Ultra Sugar Free Organic Fiber

    7 GRAMS OF FIBER PER TEASPOON DOSE

    Perfect Grind™ For Easy Mixing

    Fiber laxative for regularity
    Natural Orange Flavor

    NO ARTIFICIAL INGREDIENTS

    42 DOSES WEIGHT 10.7 OZ (300 GRAMS)

    Fill controlled by weight, not volume

    *Compared to leading NuSyllium product

    Folks are Taking about the Benefits of NuSyllium Ultra Organic Natural Fiber!

    You can use NuSyllium Ultra 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 5 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, Tea Nut-free

    GMO-free, Preservative-free

    Gluten-free, Zero Trans Fat

    Diary-free, No animal testing

    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

    Ultra organic  Sugar Free Organic Fiber
  • INGREDIENTS AND APPEARANCE
    ULTRA ORGANIC FIBER  SUGAR FREE
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-575
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGE (Orange Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-575-42300 g in 1 CANISTER; Type 0: Not a Combination Product03/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/18/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)

Related Drugs