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Fiber Lax (Rugby Laboratories)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 500 TABLET, FILM COATED in 1 BOTTLE (0536-4306-05) Label Information
TABLET, FILM COATED 2 BLISTER PACK in 1 CARTON (0536-4306-08) > 30 TABLET, FILM COATED in 1 BLISTER PACK Label Information
TABLET, FILM COATED 90 TABLET, FILM COATED in 1 BOTTLE (0536-4306-11) Label Information

Complete Fiber Lax Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    (in each captab)

    Calcium polycarbophil 625 mg


  • Purpose

    Bulk-Forming Laxative

    (equivalent to polycarbophil 500 mg)


  • 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 Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.


  • Stop use and ask a doctor if

    • you have 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.


  • DOSAGE & ADMINISTRATION

    Directions

    Take Fiber-Lax 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.

    • do not take more than 4 doses in 24 hours
    • adults & children 12 years and over: 2 captabs 1 to 4 times a day
    • children under 12 years: ask a doctor

    Other information

    • each captab contains: calcium 140 mg
    • store below 30ËšC (86ËšF) do not refrigerate protect from humidity

  • Inactive ingredients

    Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid

    Questions or comments?

    Call 1-800-645-2158, 9 am - 5 pm ET, Monday – Friday

    TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED

    *Rugby Laboratories, Inc. is not affiliated with the owner of the trademark FiberCon®.

    Fiber-Lax is distributed by Rugby Laboratories, Inc.

    Rugby®
    Duluth, Georgia 30097
    www. Rugbylaboratories.com


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    e691924b-figure-01

  • INGREDIENTS AND APPEARANCE
    FIBER LAX 
    calcium polycarbophil tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4306
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL 625 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARAMEL (UNII: T9D99G2B1R)  
    CROSPOVIDONE (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color WHITE (Off-white) Score 2 pieces
    Shape OVAL Size 19mm
    Flavor Imprint Code CPC;339
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-4306-08 2 in 1 CARTON
    1 30 in 1 BLISTER PACK
    2 NDC:0536-4306-11 90 in 1 BOTTLE
    3 NDC:0536-4306-05 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 09/01/2010
    Labeler - Rugby Laboratories (109178264)
    Registrant - Contract Pharmacal Corp (968334974)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corp 968334974 MANUFACTURE(0536-4306)