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

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UP AND UP FIBER THERAPY (PSYLLIUM HUSK) POWDER [TARGET CORPORATION]
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NDC 11673-669-72
Set ID 956c48f8-c705-4a86-9866-c68a48ddeb6c
Category HUMAN OTC DRUG LABEL
Packager TARGET CORPORATION
Generic Name
Product Class
Product Number
Application Number PART334
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient: (in each teaspoon)

    Psyllium husk approximately 3.4 g

  • Purpose

    Bulk-forming Laxative

  • Uses:

    •
    for relief of occasional constipation (irregularity)
    •
    generally produces bowel movement in 12-72 hours
  • 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 & children 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.

    Children 6-11 yrs :

    ½ adult dose in 8 ounces 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.

    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. Keep the container tightly closed to protect from humidity
    •
    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?

    1-800-910-6874

  • PRINCIPAL DISPLAY PANEL

    NDC 11673-669-72

    Compare to the Fiber Content in Metamucil® 4 in 1 Multihealth Fiber!™*

    FIBER Therapy

    100% Natural Psyllium Husk

    Multi-Benefit Daily Fiber Supplement

    •
    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**
    •
    Gluten free

    SUGAR FREE

    not a low calorie food

    ORANGE SMOOTH

    Naturally and Artificially Flavored

    72 Teaspoon‡ Doses

    NET WT 15 OZ (425 g)

    fill controlled by weight, not volume

    K

    PAREVE

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

    †See back for information about soluble fiber and heart disease.

    **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.

    DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber!™.

    GLUTEN FREE if you have specific dietary needs, you should consult your doctor before consuming this product.

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

    DISTRIBUTED BY:

    Target Corporation.

    Minneapolis., MN 55403

    TM & ©2019

    Target Sugar Free Orange Flavor 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)  
    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 artifcial) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-669-72425 g in 1 BOTTLE; Type 0: Not a Combination Product03/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/15/2018
    Labeler - TARGET CORPORATION (006961700)
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