Label: LEADER FIBER- psyllium husk capsule

  • Category: HUMAN OTC DRUG LABEL

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 February 5, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    Psyllium husk approx. 0.52 g

  • Purpose

    fiber laxative

  • Uses

    ▪
    effective in treating occasional constipation and restoring regularity
  • 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

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    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.

  • Directions

    ▪
    take at the first sign of irregularity
    ▪
    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.
    ▪
    adults and children 12 years of age and over: take 5 capsules with at least 8 oz. of liquid. Swallow capsules one at a time. May repeat dose up to 3 times a day.
    ▪
    children 12 years and under: ask a doctor
  • Other information

    ▪
    do not use if printed inner seal is torn or missing
    ▪
     store at room temperature tightly closed to protect from humidity
    ▪
     contains a 100% natural, therapeutic fiber
    ▪
    each capsule contains potassium 5 mg
  • Inactive ingredients

    blue 1, caramel color, gelatin, polysorbate 80, shellac, sodium lauryl sulfate, titanium dioxide.

  • SPL UNCLASSIFIED SECTION

    Distributed By: Cardinal Health
    Dublin OH 43017

  • PRINCIPAL DISPLAY PANEL - 100 Capsules Label

    NDC 37205-372-78

    Leader Fiber Capsules

    100% Natural Psyllium Fiber Laxative
    Relieves Constipation/
    Restores regularity

    100 CAPSULES

    Leader Fiber Capsules

    Leader Fiber Capsules

  • INGREDIENTS AND APPEARANCE
    LEADER FIBER 
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-372
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARAMEL (UNII: T9D99G2B1R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code FC119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-372-78100 in 1 BOTTLE; Type 0: Not a Combination Product08/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/16/2019
    Labeler - Cardinal Health (097537435)
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