Label: PSYLLIUM FIBER- psyllium husk powder

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 27, 2020

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

  • Supplement Facts

    Serving Size: 1 rounded Tbsp. (12 g)

    Servings per container: 30

    Amount per serving % Daily Value

    Calories 45

    Total Carbohydrate 12 g 4%*

    Dietary Fiber 3 g 11%*

    Soluble fiber 2 g ϯ

    Total sugar 8 g ϯ

    Includes 8 g Added Sugars 16%*

    Iron 0.7 mg 4%*

    Sodium 5 mg < 1%*

    Potassium 35 mg < 1%*

    *Percent Daily Values are based on a 2,000 calorie Diet

    ϯ Daily Value not established.

    Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from Psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One serving provides 2.4 grams of this soluble fiber. Consult a doctor if you are considering the Use of the product as part of a cholesterol-lowering program.

  • Directions:

    Adults 12 years & over 1: 1 rounded tablespoon (Tbsp = tablespoon), 3 times daily

    Children under 12 years: Consult a doctor. Put one serving into an empty glass and fill glass with 8 oz of water. Stir briskly and drink promptly. If mixture thickens, add more water and stir. Take up to 3 times daily

    New Users: Start with 1 serving per day; gradually increase up to 3 servings per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

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

    Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium. Ask a doctor before use if you have abdominal pain, nausea or vomiting or experience a sudden change in bowel habits persisting for 2 weeks.

    Stop use and ask a doctor if constipation lasts more than 7 days or rectal bleeding occurs. These may be signs of a serious condition.

    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.

    Keep out of reach of children.

    Do not use if printed seal under cap is missing or broken.

    Store at 20°C - 25 C (68°F - 77°F)

  • WARNING:

    Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/food.

    Ingredients: Sucrose, Psyllium Husk, Citric Acid, Natural and Artificial Orange Flavor, Silicon Dioxide, FD&C Yellow #6.

    Manufactured for and Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 10/20 GP

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0714-92
    Marlex Pharmaceuticals
    Psyllium Fiber Powder
    Orange Flavor      
    368 g (13 oz)

    PRINCIPAL DISPLAY PANEL
NDC 10135-0714-92
Marlex Pharmaceuticals
Psyllium Fiber Powder 
Orange Flavor	
368 g (13 oz)

    Revised: 10/2020

    Document Id: 702fbfb7-cb08-4fda-a344-9c913f35bed1

    58476-3

    Set id: afa81aad-6ada-4275-9946-e9fceb62bfe9

    Version: 1

    Effective Time: 20201006

    Marlex Pharmaceuticals, Inc.

  • INGREDIENTS AND APPEARANCE
    PSYLLIUM FIBER 
    psyllium husk powder
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10135-714
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK2.4 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:10135-714-92368 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/01/2020
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    flavor
    Labeler - Marlex Pharmaceuticals Inc (782540215)