UP AND UP FIBER THERAPY (PSYLLIUM HUSK) POWDER [TARGET CORPORATION]

UP AND UP FIBER THERAPY (PSYLLIUM HUSK) POWDER [TARGET CORPORATION]
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NDC 11673-669-91
Set ID 674753ee-1174-4c06-9ed3-a090b338a39e
Category HUMAN OTC DRUG LABEL
Packager Target Corporation
Generic Name
Product Class
Product Number
Application Number PART334
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient: (in each TEASPOON)

    Psyllium husk approximately 3.4 g

  • Purpose

    Fiber therapy for regularity

  • Uses:

    for relief of occasional constipation (irregularity)
  • 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 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 6 – 11 yrs :

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

    Children under 6 yrs:

    Consult a doctor

    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 increased fiber intake, you may experience changes in bowel habits or minor bloating.

    New Users

    Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

  • Other information:

    each teaspoon contains: potassium 35 mg; sodium 5 mg
    PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
    store at room temperature tightly closed to protect from humidity
    do not use if printed inner seal is broken or missing
    contains a 100% natural, therapeutic fiber
  • Inactive ingredients:

    aspartame, citric acid, FD&C yellow 6, maltodextrin, natural and artificial orange flavor, silica.

    Questions or comments?

    Call 1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    NDC 11673-669-91

    Compare to active ingredient in Metamucil® 4 in 1 MultiHealth Fiber***

    fiber therapy

    100% natural psyllium husk

    multi-benefit daily fiber supplement therapy for regularity

    helps you feel less hungry between meals**

    helps maintain healthy blood sugar levels as part of your diet**

    helps lower cholesterol to promote heart health†

    promotes digestive health**

    sugar free

    not a low calorie food

    ORANGE FLAVOR 114 DOSES‡

    FILL CONTROLLED BY WEIGHT NOT VOLUME

    114 TEASPOON DOSES‡

    NET WT 23.3 OZ (1.4 LB) 660 g

    Naturally and Artificially Flavored

    245 05 0216 R01 ID295403

    Distributed by Target Corporation

    Minneapolis, MN 55403

    ©2015 Target Brands, Inc.

    Shop Target.com

    GLUTEN FREE

    **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.

    †See back for information about soluble fiber and heart disease

    ‡Serving size varies. See DIRECTIONS on back panel for more information

    This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

    100% satisfaction guaranteed or your money back.

    ***This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Metamucil ®.

    up and up fiber therapy 100%natural psyllium husk
  • INGREDIENTS AND APPEARANCE
    UP AND UP FIBER THERAPY 
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-669
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.79 g
    Inactive Ingredients
    Ingredient NameStrength
    aspartame (UNII: Z0H242BBR1)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBROWN (Light yellowish) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-669-91660 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/26/2015
    Labeler - Target Corporation (006961700)