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 November 18, 2021

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  • Drug Facts

    Active ingredient (in each tablet)
    Calcium polycarbophil 625 mg
    (equivalent to polycarbophil 500 mg)

  • Purpose

    Purpose
    Bulk-forming laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • 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.

    Ask a doctor before use if you have

    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits that persists over a period of 2 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.

    When using this product

    • do not use for more than 7 days unless directed by a doctor

    • do not take more than 8 tablets in a 24-hour period unless directed by a doctor

    Stop use and ask a doctor if

    • you fail to have a bowel movement after use or have rectal bleeding.

    These could 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 (1-800-222-1222) right away.

  • Directions

    • take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning

    • dosage will vary according to diet, exercise, previous laxative use or severity of constipation

    • continued use for 1 to 3 days is normally required to provide full benefit

    adults and children 12 years and over2 tablets, 1 to 4 times per day
    children under 12 yearsask a doctor

  • Other information

    • each tablet contains: calcium 140 mg

    • do not use if printed seal under cap is torn or missing
    • store in a dry place at 15° – 30°C (59° – 86°F).

    • protect contents from moisture

  • 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

    *This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark FiberCon®

    WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

    Distributed by: Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www. Rugbylaboratories.com

  • PRINCIPAL DISPLAY PANEL

    Rugby

    NDC 0536-4306-05

    Comapare to Active ingredient in FiberCon*

    Fiber-Lax

    Calcium Polycarbophil 625 mg

    Bulk-Forming Laxative

    Safe and Effective Relief of Occasional Constipation

    Promotes Regularity

    500 Captabs

    Rugby Label

  • 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 (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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