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Natural Fiber Powder (Medline Industries, Inc.)

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POWDER 283 g in 1 BOTTLE (53329-101-55) Label Information

Complete Natural Fiber Powder Information

  • Active ingredient

    Psyllium husk 3.4g (per each rounded teaspoon = 5.8g)

  • Purpose

    Bulk-forming laxative

  • Use

    • effective in treating occasional constipation and restoring regularity

  • Warnings

    Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled 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

  • Ask a doctor or pharmacist before use if you are

    taking any other drug. Laxatives may affect how other drugs work.

  • When using this product

    â–  do not exceed the maximum recommended daily dosage in a 24-hour period
    â–  you may experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake

  • Stop use and ask a doctor if

    • constipation lasts more than 7 days
    • rectal bleeding occurs

    These could 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.

  • Directions

    â–  take at the first sign of irregularity up to 3 times a day

    â–  put one dose into an empty glass
    â–  fill glass with 8oz of water or favorite beverage
    â–  stir briskly and drink promptly
    â–  if mixture thickens add more water and stir
    â–  take 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.
    â–  If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
    â–  New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary

    adults and children 12 years and over: 1 rounded teaspoon in 8 ounces of liquid
    6 to under 12 years: 1/2 teaspoon in 8 ounces of liquid
    under 6 years: ask a doctor

  • Other information

    • each teaspoon contains: potassium 30 mg and sodium 5 mg
    • Phenylketonurics: contains phenylalanine 25 mg per teaspoon
    • store at (20º-25ºC) 68º-77ºF

  • Inactive ingredients

    aspartame, citric acid, FD and C yellow No.6, maltodextrin, natural and artificial orange flavor

  • Principal Display Panel

    Medline Natural Fiber Powder

    100% Natural Psyllium Husk Fiber

    Sugar Free Orange Flavor

    image of Psyllium Husk OTC49110.jpg

    psyllium husk powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-101
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Plantago seed (UNII: 9C60Y73166) (Plantago seed - UNII:9C60Y73166) Plantago seed 3400 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Aspartame (UNII: Z0H242BBR1)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor ORANGE (Orange Flavor) Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-101-55 283 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/01/2009
    Labeler - Medline Industries, Inc. (025460908)
    Name Address ID/FEI Business Operations
    Guardian Drug Company 119210276 manufacture(53329-101)