Label: LEADER NATURAL FIBER- psyllium husk powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each TEASPOON)

    Psyllium husk approximately 3.4 g

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  • Purpose

    Fiber laxative

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  • Uses

    • effective in treating occasional constipation and restoring regularity
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  • 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 doctor or a Poison Control Center right away.

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  • 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 yrs. & 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.
    6 – 11 yrs: ½ adult dose in 8 oz of liquid, up to 3 times daily
    Under 6 yrs:
    Consult a doctor

    Laxatives, 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 increase to 3 doses per day as necessary.

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  • Other information

    • each teaspoon 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
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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: CARDINAL HEALTH

    DUBLIN OH 43017

    CIN 4553657

    www.myleader.com

    1-800-200-6313

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  • PRINCIPAL DISPLAY PANEL

    LEADER® Natural Fiber

     Compare to Metamucil® MultiHealth Fiber

    Smooth Texture

    Sugar Free

    Natural Fiber

    Fiber Laxative/Dietary supplement

    100% Natural Psyllium Fiber

    Fiber Supplement

    Orange Flavored Powder

    Not a low calorie product

    Relieves Constipation

    Restores Regularity

    fill controlled by weight not volume

    NET WT 10 OZ (283 g)

    48 SERVINGS

    Leader Smooth Texture Sugar Free Natural Fiber 48 Servings

    Leader Smooth Texture Sugar Free Natural Fiber 48 Servings

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  • INGREDIENTS AND APPEARANCE
    LEADER  NATURAL FIBER
    psyllium husk powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-667
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Psyllium Husk (Psyllium Husk) Psyllium Husk 3.4 g  in 5.8 g
    Inactive Ingredients
    Ingredient Name Strength
    aspartame  
    citric acid monohydrate  
    FD&C Yellow No. 6  
    maltodextrin  
    SILICON DIOXIDE  
    Product Characteristics
    Color BROWN Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-667-10 283 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 07/01/2012
    Labeler - Cardinal Health (097537435)
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