Label: QUALITY CHOICE FIBER LAXATIVE- psyllium husk capsule

  • NDC Code(s): 63868-348-01
  • Packager: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 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

    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

    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. Generally produces effect in 12-72 hours
    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
    do not use if printed inner seal under cap is broken or missing
  • Inactive ingredients

    caramel color, edible ink, gelatin, polysorbate 80

    Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 160 Capsules Label

    Quality Choice®

    NDC 63868-348-01

    Compare to Metamucil® Capsules

    Fiber Capsules

    Psyllium Husk
    Fiber Laxative/Dietary Supplement

    Helps lower cholesterol to promote heart health†

    Promotes digestive health**

    Helps maintain healthy blood sugar levels as part of your diet*

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

    160 Capsules

    Distributed by: C.D.M.A. Inc.,

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

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

    Quality Choice Fober Capsules 160 count
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE  FIBER LAXATIVE
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-348
    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:63868-348-01160 in 1 BOTTLE; 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 - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)