Label: CAREONE ORANGE FLAVORED- psyllium husk powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 25, 2024

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

  • 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
    PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
    contains a 100% natural, therapeutic fiber
    store at room temperature tightly closed to protect from humidity
  • Inactive ingredients:

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

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    CAREONE

    NDC# 41520-515-14

    Compare to the fiber content in Metamucil® 4 in 1 MultiHealth Fiber! ™*

    FIBER SUPPLEMENT POWDER

    Psyllium Husk Fiber

    Orange Flavored

    NATURALLY AND ARTIFICIALLY FLAVORED

    HELPS LOWER CHOLESTEROL TO PROMOTE HEART HEALTH†
    BULK FORMING LAXATIVE/DIETARY FIBER SUPPLEMENT

    Sugar Free not a low calorie food.

    114 teaspoon doses

    NET WT 23.3 OZ (1 LB 7.3 OZ) 660 g

    OUR PHARMACISTS RECOMMEND

    114 DOSE‡

    Packaged by weight, not volume. Content may settle during shipping and handling.

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

    ‡Serving size varies. See DIRECTIONS on back panel for more information

    **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.

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

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

    GLUTEN FREE (may contain trace amounts less than 20 ppm). 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

    FOODHOLD, U.S.A., LLC

    LANDOVER, MD 20785

    1-877-846-9949

    © 2018 S&S Brands, LLC

    Quality guaranteed or your money back

    Package Label 114 Teaspoons Doses

    CareOne Fiber Supplement Powder Orange Flavored
  • INGREDIENTS AND APPEARANCE
    CAREONE  ORANGE FLAVORED
    psyllium husk powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 5.8 g
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorBROWN (Light Yellowish) Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-515-14660 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/18/2019
    Labeler - FOODHOLD USA (809183973)