Label: KROGER NATURAL FIBER SUGAR FREE- psyllium husk powder

  • 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 October 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient: (in each TEASPOON)

    Psyllium husk 3.4 g

  • Purpose

    Fiber Laxative

  • Uses:

    ▪
    effective in treating occasional constipation and restoring 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 if

    ▪
    constipation lasts more than 7 days
    ▪
    rectal bleeding occurs

    These may be signs 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 thickens, add more liquid and stir.

    Adults 12 years & older:

    1 rounded TEASPOON in 8 ounces of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

    6-11 yrs:

    ½ adult dose in 8 ounces of liquid, up to 3 times daily

    Under 6 yrs:

    Consult a doctor

    Laxative, including bulk fibers 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 increased fiber intake, you may experience changes in bowel habits or minor bloating.

    New Users:

    Start with 1 dose per day; gradually increased to 3 doses per day as necessary.

  • Other information:

    ▪
    each tablespoon contains: potassium 30 mg; sodium 5 mg
    ▪
    PHENYLKETONURICS:CONTAINS PHENYLALANINE, 25 mg per teaspoon
    ▪
    store at room temperature tightly closed to protect from humidity
    ▪
    contains a 100% natural, therapeutic fiber
  • Inactive ingredients:

    aspartame, citric acid, FD&C Yellow No. 6, natural and artificial orange flavor, silica, sucrose.

    Questions or comments?

    1-800-632-6900

  • PRINCIPAL DISPLAY PANEL

    Kroger®

    QUALITY GUARANTEED

    NDC 30142-515-14

    COMPARE TO ACTIVE INGREDIENT OF Metamucil® MultiHealth Fiber*.

    *See Back Panel

    Sugar FreeSmooth Texture

    Natural Fiber

    Orange Flavor

    100% Natural Psyllium Husk

    Fiber Laxative/Fiber Supplement

    Naturally and Artificially Flavored

     
    HelpsLower Cholesterol

    See back for information about soluble fiber and heart disease.

    114 Teaspoon Doses

    NET WT 23.3 OZ 660 g

    Fill controlled by weight, not volume

    Our Pharmacists Recommend

    K PAREVE

    QUALITY GUARANTEED (if you are not completely satisfied with this product, return it for a refund or replacement.

    Comments or Questions?

    800-632-6900 www.kroger.com

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    *Metamucil® is a registered trademark of Procter & Gamble, Cincinnati, OH 45202. Procter & Gamble is not affiliated with The Kroger Co. or this product.

    DISTRIBUTED BY THE KROGER CO.

    CINCINNATI, OHIO 45202

    MADE IN U.S.A.

    Kroger Sugar Free Natural Fiber 114 Teaspoon Doses
  • INGREDIENTS AND APPEARANCE
    KROGER NATURAL FIBER  SUGAR FREE
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.8 g
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBROWN (Light Yellowish) Score    
    ShapeSize
    FlavorORANGE (natural and artificial) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-515-14660 g in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/16/2019
    Labeler - KROGER COMPANY (006999528)
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