QUALITY CHOICE (PSYLLIUM HUSK) POWDER, FOR SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

QUALITY CHOICE (PSYLLIUM HUSK) POWDER, FOR SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-347-17, 63868-347-19, 63868-347-23
Set ID 118fc254-7964-418a-a359-558d853a91f5
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient (in each TEASPOON)

    Psyllium husk approximately 3.4 g

  • Purpose

    Fiber therapy for regularity

  • Uses

    for relief of occasional constipation (irregularity)
  • Warnings

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

    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.

    Ask a doctor before use if you have

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

    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 thickness, add more liquid and stir.

    Adults 12 years & older:

    1 rounded TEASPOON in 8 oz of liquid at the signs 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 oz of liquid, up to 3 times daily

    Under 6 yrs:

    Consult a doctor

    Bulk-forming fibers like psyllium husk may affect how well other medicines work. If t=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 increase to 3 doses per day as necessary

  • Other information

    each teaspoon contains: potassium 30 mg and sodium 5 mg
    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

    silica, sucrose.

    Questions or comments?

    1-866-467-2748

  • Fiber Supplement Information

    Uses:

    Daily fiber supplement. Each serving adds 3 grams of fiber to your diet.
    For lowering cholesterol to promote heart health. Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One adults dose of this products has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as a part of a cholesterol lowering program.

    Warnings Read entire label, including warnings in Drug Facts.

    Directions Adults 12 years and older: put 1 rounded TEASPOON in to an empty glass and mix with 8 oz of liquid up to 3 times daily for daily fiber supplement; 3 times daily to help maintain healthy blood sugar levels† and for cholesterol lowering to promote heart health.

    under 12 years: Consult a doctor.

    See mixing directions in Drug Facts.

    NOTICE: Mix this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See choking warning.

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

  • Principal Display Panel

    QUALITY CHOICE®

    NDC# 63868-347-17

    Compare to the active ingredient in Metamucil® MultiHealth Fiber*

    Natural Fiber Powder

    100% Natural Psyllium Husk

    Daily Fiber Supplement | Therapy for Regularity

    Helps Lower Cholesterol to Promote Heart Health**

    Promotes Digestive Health†

    Helps Maintain Healthy Blood Sugar Levels as Part of Your Diet**†

    Gluten Free

    Unflavored Original Coarse

    **See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

    48 teaspoon doses

    K PAREVE

    Net Wt. 13 oz (368g)

    fill controlled by weight, not volume

    100% QC SATISFACTION GUARANTEED

    †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.

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

    Distributed by C.D.M.A., Inc. ©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    QC(CDMA) Natural Fiber Powder 48 teaspoons doses
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE 
    psyllium husk powder, for suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-347
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-347-17368 g in 1 CANISTER; Type 0: Not a Combination Product04/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/17/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)