Label: BEST CHOICE FIBER LAXATIVE- psyllium husk capsule

  • NDC Code(s): 63941-119-10
  • Packager: BEST CHOICE (VALU MERCHANDISERS COMPANY)
  • 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 August 17, 2023

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  • 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 ounces 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. Keep the container 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

    Best Choice®

    NDC 63941-119-10

    COMPARE TO THE ACTIVE INGREDIENT IN METAMUCIL® CAPSULES 3 IN 1 MULTIHEALTH FIBER!™*

    Psyllium Capsules

    100% Natural Psyllium Husk
    Fiber Laxative/Dietary Supplement

    •
    Helps maintain healthy blood sugar levels as part of your diet*†
    •
    Helps lower cholesterol to promote heart health†
    •
    Promotes digestive health**
    •
    Gluten Free

    See fiber supplement information about soluble fiber and heart disease and maintaining healthy blood sugar levels.

    100 CAPSULES

    **THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINSTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

    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)

    PROUDLY DISTRIBUTED BY:

    VALU MERCHANDISERS, CO.

    5000 KANSAS AVE

    KANSAS CITY, KS 66106

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

    Best Choice Psyllium Husk 100 Capsules
  • INGREDIENTS AND APPEARANCE
    BEST CHOICE  FIBER LAXATIVE
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-119
    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:63941-119-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/16/2019
    Labeler - BEST CHOICE (VALU MERCHANDISERS COMPANY) (868703513)
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