Label: ONELAX FIBER THERAPY ORIGINAL COARSE- psyllium husk powder

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 18, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient: (in each teaspoon)

    Psyllium husk approximately 3.4 g

  • Purpose

    Bulk-forming Laxative

  • Uses:

    • for relief of occasional constipation (irregularity)
    • generally produces bowel movement in 12-72 hours
  • 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 Poison Control Center right away at 1-800-222-1222.

  • 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 & children 12 years & older:

    1 rounded teaspoon in 8 ounces of liquid at the first sign of irregularity. Can be taken up to 3 times daily.

    Children 6 – 11 yrs:

    ½ adult dose in 8 ounces of liquid, up to 3 times daily

    Children under 6 yrs:

    Consult a doctor

    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. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

    New Users

    Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

  • Other information

    • each teaspoon contains: potassium 35 mg; sodium 5 mg
    • store at room temperature. Keep the container tightly closed to protect from humidity
    • contains a 100% natural, therapeutic fiber
  • Inactive ingredients

    citric acid, colloidal silicon dioxide, FD&C Yellow No.6, maltodextrin, orange flavor, sodium benzoate, sucralose.

    Questions or comments ?

    Call toll-free 1-877-225-6999.

    Supplement Facts

    SF

  • PRINCIPAL DISPLAY PANEL

    13oz

  • INGREDIENTS AND APPEARANCE
    ONELAX FIBER THERAPY  ORIGINAL COARSE
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-6586
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-6586-3368 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2023
    Labeler - Akron Pharma Inc. (067878881)
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