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Natural Fiber Therapy (Major Pharmaceuticals)

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POWDER, FOR SOLUTION 368 g in 1 BOTTLE (0904-5200-65) Label Information

Complete Natural Fiber Therapy Information

  • Drug Facts

    Active ingredient (in each rounded TABLESPOON)

    Psyllium husk approximately 3.4 g


  • Purpose

    Bulk-forming laxative


  • Uses

    • effective in treating occasional constipation and restoring regularity.

  • 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 accidental overdose, seek professional assistance or contact a Poison Control Center right away.


  • Directions

    Put one does 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 & Childrent 12 years & over

    1 rounded TABLESPOON 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 to under 12 years 1/2 adult dose in 8 oz of liquid, up to 3 times daily.
    Children under 6 years 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.


  • OTHER SAFETY INFORMATION

    Other information

    • each tablespoon contains: potassium 30 mg; sodium 5 mg
    • store below 30ºC (86ºF)
    • protect contents from humidity. Keep tightly closed.

  • Inactive Ingredients

    citric acid, fd&c yellow no. 6, fd&c yellow no. 6 lake, natural orange flavor and sucrose


  • Questions and Comments?

    (800) 616-2471


  • DIETARY FIBER SUPLEMENT

    Uses 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 adult dose of this product has 2.4 grams of this soluble fiber. Consult a doctor if you are considering use of this product as part of a cholesterol-lowering program.

    Warnings Read entire label, including warnings in Drug Facts.

    Directions Adults 12 years & older : 1 rounded TABLESPOON in 8 oz of liquid 3 times daily.

    under 12 years : Ask a doctor. See mixing directions in Drug Facts.

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

    Supplement Facts

    Serving Size 1 rounded tablespoon (12g)

    Servings Per Container 30

    Amount Per Serving %DV**
    Calories 45
    Total Carbohydrates 12 g 4%
    Dietary Fiber 3 g 12%
    Soluble Fiber 2 g *
    Sugars 9 g *
    Iron 0.8 mg 4%
    Sodium 5mg <1%
    Potassium 30mg <1%

    **% Daily Value (DV) is based on a 2,000 Calorie Diet.

    *Daily Value (DV) not established.

    INGREDIENTS : sucrose, psyllium husk, citric acid, natural orange flavor, FD&C yellow No. 6 and FD&C Yellow #6 lake


  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by: MAJOR ® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152

    Re-Order No. 013236

    M-29 Rev 08/17

    7982-08-17


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 0904-5200-65

    MAJOR®

    Natural Fiber Therapy 100% natural psyllium husk fiber

    Bulk forming Laxative/Dietary Fiber Supplement

    Original Texture

    See back for information about soluble fiber and heart disease

    Naturally Flavored

    Orange Flavor

    30 Tablespoon Doses

    Net Wt. 13 oz (368g)

    Fill controlled by weight, not volume

    3010-major-label


  • INGREDIENTS AND APPEARANCE
    NATURAL FIBER THERAPY  NATURAL LAXATIVE
    psyllium husk powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5200
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 3.4 g  in 7 g
    Inactive Ingredients
    Ingredient Name Strength
    ORANGE (UNII: 5EVU04N5QU)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color brown (Tannish Yellow) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5200-65 368 g in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2011
    2 NDC:0904-5200-66 538 g in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/02/2011
    Labeler - Major Pharmaceuticals (191427277)