Label: FIBER LAX- calcium polycarbophil tablet, film coated

  • NDC Code(s): 0536-4306-05, 0536-4306-08, 0536-4306-11
  • Packager: Rugby Laboratories
  • 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 May 18, 2020

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  • 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.

  • 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 30˚C (86˚F) • 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

  • SPL UNCLASSIFIED SECTION

    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®.

    Distributed by: Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www. Rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    ​This Package for Households without young children

    Rugby

    NDC 0536-4306-05

    Safe and Effective Relief of Occasional Constipation

    Fiber-Lax

    Bulk-Forming Laxative

    Promotes Regularity
    Non-habit Forming

    500 Captabs

    Comapare to Active ingredient in FIBERCON*

    0339-Rugby

  • INGREDIENTS AND APPEARANCE
    FIBER LAX 
    calcium polycarbophil tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4306
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (Off-white) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code CPC;339
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-4306-082 in 1 CARTON09/01/2010
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0536-4306-1190 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2010
    3NDC:0536-4306-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/2010
    Labeler - Rugby Laboratories (079246066)
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