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Reguloid (Rugby Laboratories)

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CAPSULE 160 CAPSULE in 1 BOTTLE (0536-1500-60) Label Information

Complete Reguloid Information

  • Drug Facts

    Active ingredient (in each capsule)

    Psyllium husk (appx. 0.52 g)


  • Purpose

    Bulk-Forming Laxative


  • Uses

    • relieves occasional constipation
    • 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.

    Do not use

    longer than one week

    Ask a doctor before use if you have
    • abdominal pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that lasts over two weeks

    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

    you experience rectal bleeding

    • you fail to have a bowel movement after using this product.

      These may indicate 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 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 & children 12 years and over: Take 5 capsules with 8 ounces of liquid (swallow one capsule at a time) at the first sign of irregularity. May be taken up to 3 times daily
    • children under 12 years: ask a doctor


  • SPL UNCLASSIFIED SECTION

    Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in Reguloid, may reduce the risk of heart disease.

    SEE WARNINGS AND DIRECTIONS IN DRUG FACTS.

    Dosage: adults & children 12 years and over: 2-6 capsules.

    Children under 12 years: ask a doctor.

    Supplement Facts

    Serving Size 6 Capsule

    Serving per container 26

    Amount per serving %DV**
    Calories 10
    Total Carbohydrates 3 g 1%
    Dietary Fiber 3 g 11%
    Soluble Fiber 2 g

    †

    Iron 0.4 mg 2%
    Potassium 30 mg <1%

    **% Daily Values (DV) are based on a 2000 calorie diet

    † Daily Value not established.


  • Other ingredients

    Gelatin, polysorbate 80, FD&C yellow #6 Lake, potassium sorbate, citric acid and edible ink.


  • Questions or comments?

    1-800-645-2158

    www.rugbylaboratories.com


  • SPL UNCLASSIFIED SECTION

    Keep tightly closed to protect from humidity. Store between 15Ëš-30ËšC (59Ëš-86ËšF).

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *Rugby Laboratories is not affiliated with the owner of the trademark Metamucil ®

    Distributed by:

    Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI 48150


  • PRINCIPAL DISPLAY PANEL

    Rugby ®

    Compare to Active Ingredient in Metamucil ®

    NDC 0536-1500-60

    Reguloid ®

    Bulk-Forming Laxative

    and Dietary Fiber Supplement

    160 Banded Capsules

    3860-label


  • INGREDIENTS AND APPEARANCE
    REGULOID 
    psyllium capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1500
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 0.52 g
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    Color brown (Light brown, banded yellow around the middle) Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1500-60 160 in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2010 11/30/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/28/2010 11/30/2019
    Labeler - Rugby Laboratories (079246066)