Label: CERTI-CET PLUS EXTRA STRENGTH- acetaminophen 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 April 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (each tablet)

    Acetaminophen 500 mg

  • Purpose

    Analgesic/Antipyretic

  • Uses

    • Temporary relief of minor aches and pains associated with:
      • common colds
      • headache
      • toothache
      • muscular aches
      • backache
      • arthritis
      • menstrual cramps
    • and reduction of fever.
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if user has liver disease.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask doctor if

    • symptoms do not improve
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • a rare sensitivity reaction occurs.

    If pregnant or breast-feeding

    • ask a health professional before use.

    Keep out of the reach of children

    • In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Do not exceed recommended dosage.

  • Directions

    • Adults and children 12 years of age and older
    		Take 2 tablets every 4 to 6 hours as needed.
    Do not take more than 8 tablets in 24 hours.
    • Children under 12 years of age
    		Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
  • Other information

    • store at room temperature 15-30°C (59-86°F)
    • use by expiration date on package.
    • read all product information before using.
  • Inactive ingredients

    • corn starch, hydroxypropyl methylcellulose, pregelatinized starch, stearic acid, titanium dioxide.

    May contain providone and sodium starch glycolates.

  • Questions?

    Call 1-800-854-7474

  • PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box

    Tamper evident
    packaging:
    Do not use if
    open or torn.

    This package for
    households
    without children

    See New Warnings
    Information

    Compare to Tylenol®

    CERTI-CET
    PLUS    ™

    EXTRA STRENGTH
    500 mg Acetaminophen

    • Pain Reliever
    • Fever Reducer
    • Analgesic
    • Antipyretic
    PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box
  • INGREDIENTS AND APPEARANCE
    CERTI-CET PLUS   EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-310
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48083-310-2725 in 1 BOX12/29/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:48083-310-3050 in 1 BOX12/29/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:48083-310-33125 in 1 BOX12/29/2017
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:48083-310-36250 in 1 BOX12/29/2017
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:48083-310-39500 in 1 BOX12/29/2017
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:48083-310-3150 in 1 BOX12/29/2017
    62 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/29/2017
    Labeler - Certified Safety Manufacturing (788460483)
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