Label: ORIGINAL TEXTURE ORANGE FLAVOR  - psyllium husk powder, for suspension 

  • Label RSS
  • 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 09/12

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

  • Active ingredient (per each rounded tablespoon=11 g)

    Psyllium husk 3.4 g

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  • Purpose

    Bulk-forming laxative

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  • Uses

    • effective in treating occasional constipation and restoring regularity
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  • 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

    • do not exceed the maximum recommended daily dosage in a 24-hour period
    • 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.
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  • Directions

    • take at the first sign of irregularity up to 3 times a day
    • put one dose into an empty glass
    • fill glass with 8oz of water or favorite beverage
    • stir briskly and drink promptly
    • if mixture thickens add more water and stir
    • 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.
    • if you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine.
    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 tablespoon                         
    6 to under 12 years
    1/2 tablespoon
    under 6 years
    ask a doctor

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  • Other information

    • each tablespoon contains: potassium 30 mg and sodium 5 mg
    • store at (20o-25oC) 68o-77oF
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  • Inactive ingredients

    citric acid, FD and C yellow 6, natural and artificial flavor, silicon dioxide, sucrose

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

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  • Fiber Supplement information

    Uses 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 ADULT serving provides 2.4 grams of soluble fiber. Consult a doctor if you are considering use of the products as part of a cholesterol-lowering program.

    Warnings Read entire label, including warnings in Drug Facts

    Directions Adults 12 years and older: 1 rounded TABLESPOON (tbsp) in 8 oz  of liquid 3 times daily.

    Children under 12 years:  Consult a doctor.

    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 havbe difficulty swallowing.  See choking warning.

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  • PDP

    Sunmark

    compare to the active ingredient in Metamucil®

    fiber Original Texture

    Bulk-forming laxative

    Dietary fiber supplement

    100% Natural Psyllium Seed Husk Fiber

    Orange Flavor

    Naturally and Artificially Flavored

    48 Tablespoon doses

    Net wt 19 oz  (1.1 LBS 3 OZ) (538 g)

    Fill controlled by weight, not volumeoriginal texture orange flavor

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  • INGREDIENTS AND APPEARANCE
    ORIGINAL TEXTURE ORANGE FLAVOR  
    psyllium husk powder, for suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-047
    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 11 g
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    SUCROSE  
    ANHYDROUS CITRIC ACID  
    FD&C YELLOW NO. 6  
    Product Characteristics
    Color brown Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-047-65 538 g in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 12/27/2006
    Labeler - Sunmark (177667227)
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