Label: CAREONE- psyllium husk capsule

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

Drug Label Information

Updated July 20, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Psyllium husk approximately 0.52 g

  • Purpose

    Bulk Forming Laxative

  • Uses

    • effective in treating occasional constipation and restoring regularity.
    • This product generally produces bowel movement in 12 to 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

    • Take this product 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.
    • Adults 12 years and older:5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily.
    • children 12 years and under:Ask a doctor
    • Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication 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.
  • Other information

    • each capsule contains: potassium 5 mg
    • capsules are sealed using a band around the middle
    • store at room temperature tightly closed to protect from humidity
    • contains a 100% natural, therapeutic fiber
  • Inactive ingredients

    caramel color, edible ink, gelatin, polysorbate 80

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 160 Capsules Label

    NDC 41520-907-60

    Compare to Metamucil ®Capsules 3 in 1 Multihealth Fiber!™

    FIBER CAPSULES

    Psyllium Husk Fiber Supplement

    100% naturalPsyllium Husk

    BULK FORMING LAXATIVE
    DIETARY FIBER SUPPLEMENT

    160 CAPSULES

    OUR PHARMACISTS RECOMMEND

    **THESE STAEMENTS HAVE NOT BEEN EVALUATED BY FOOD AND DRUG ADMINSTRATION, THIS PRODUCT IS NOT INTEDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE

    GLUTEN FREE (may contain trace amount less than 20 ppm). If you have specific dietary needs, you should dietary needs; you should consult your doctor before consuming this product)

    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.

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ®3 in1 MultiHealth Fiber!™.

    Careone Fiber Capsule 160 counts
  • INGREDIENTS AND APPEARANCE
    CAREONE 
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-907
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK0.52 g
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code RP119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-907-60160 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/16/2019
    Labeler - FOODHOLD USA (809183973)