Label: LIDL ORANGE SMOOTH FIBER POWDER NATURALLY AND ARTIFICIALLY FLAVORED- 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 October 3, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient: (in each TABLESPOON)

    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 an 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 TABLESPOON in 8 oz 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 oz 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.

    New Users

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

  • Other information:

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

    citric acid, FD&C yellow 6, natural and artificial orange flavor, silica, sucrose.

    Questions or comments?

    1-844-656-5151

  • PRINCIPAL DISPLAY PANEL

    NDC 71141-145-32

    Made with Real Sugar

    ORANGE SMOOTH

    FIBER POWDER NATURALLY & ARTIFICIALLY FLAVORED

    Compare to Psyllium in Metamucil® 4 in 1 MultiHealth Fiber*

    Fiber POWDER

    100% NATURAL PSYLLIUM HUSK

    Bulk forming laxative/fiber supplement

    Helps you feel less hungry between meals**
    Helps maintain healthy blood sugar levels as part of your diet**
    Helps lower cholesterol to promote heart health†
    Promotes digestive health**
    Gluten free

    NET WT 30.4 OZ (861g)

    fill controlled by weight, not volume

    †See back for information about soluble fiber and heart disease.

    **These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® 4 in 1 MultiHealth Fiber.

    GLUTEN FREE

    If you have specific dietary needs, you should consult your doctor before consuming this product.

    This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels.

    DISTRIBUTED BY:

    Lidl US, LLC

    3500 S. Clark Street

    Arlington, VA 22202

    QUESTIONS?

    1-844-656-5151

    www.lidl.com

    LIDL ORANGE SMOOTH FIBER POWDER NATURAL Psyllium Husk
  • INGREDIENTS AND APPEARANCE
    LIDL ORANGE SMOOTH FIBER POWDER  NATURALLY AND ARTIFICIALLY FLAVORED
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71141-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorORANGE (naturally and artificially) Imprint Code RP145
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71141-145-32861 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/15/2018
    Labeler - LIDL US, LLC (079389709)