FIBER LAXATIVE (PSYLLIUM HUSK) CAPSULE [RARITAN PHARMACEUTICALS INC]

FIBER LAXATIVE (PSYLLIUM HUSK) CAPSULE [RARITAN PHARMACEUTICALS INC]
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NDC 68163-119-25
Set ID 22e927bd-5734-424e-8870-1aaa18f1265e
Category HUMAN OTC DRUG LABEL
Packager Raritan Pharmaceuticals Inc
Generic Name
Product Class
Product Number
Application Number PART334
  • 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 ounces. 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
    store at room temperature. Keep tightly closed to protect from humidity
    contains a 100% natural, therapeutic fiber

    WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

  • Inactive ingredients

    caramel color, edible ink, gelatin, polysorbate 80

  • PRINCIPAL DISPLAY PANEL - 25 Capsules Label

    NDC 68163-119-25

    Compare to the active ingredient in Metamucil® Capsules 3 in 1 MultiHealth Fiber!™*

    100% Natural Psyllium Husk

    Fiber Capsules
    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 (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product.

    †See back for information about soluble fiber and heart disease

    25 Capsules

    Mfg. by: Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick, NJ 08816

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

    DRx Choice Fiber Capsules 25 Counts
  • INGREDIENTS AND APPEARANCE
    FIBER LAXATIVE 
    psyllium husk capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-119
    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:68163-119-2525 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 not finalpart33404/16/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)

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