Label: FIBER LAX tablet

  • 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 July 30, 2010

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  • DRUG FACTS

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Calcium Polycarbophil 625mg (equivalent to polycarbophil 500mg)

  • 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 attention.

    Do not use

    for 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.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison 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.

    -take dose 1-4 times daily - do not take more than 4 doses in 24 hours.

    -adults & children 12 years and over: 2 captabs

    -children under 12 years: ask a doctor

  • OTHER INFORMATION

    each captab contains: calcium 140mg

  • STORAGE

    -store below 30 degrees C (86 degrees F)

    -do not refrigerate

    -protect from humidity

  • INACTIVE INGREDIENTS

    Anhydrous lactose, caramel powder, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl and stearic acid.

  • QUESTIONS OR COMMENTS?

    Questions and Comments?

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

    Repackaged by:

    Contract Pharmacy Services-PA
    125 Titus Ave Suite 200
    Warrington, PA 18976 USA

    Original--08/2010--NJW

  • Package Label

    Blister of 30

    Blister of 30

  • INGREDIENTS AND APPEARANCE
    FIBER LAX 
    fiber lax tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-205(NDC:0536-4306)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (CALCIUM - UNII:SY7Q814VUP) CALCIUM POLYCARBOPHIL500 mg
    Product Characteristics
    ColorWHITE (Beige) Score2 pieces
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-205-3030 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/09/2010
    Labeler - Contract Pharmacy Services-PA (945429777)
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