Label: CONRX 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 February 11, 2013

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  • SPL UNCLASSIFIED SECTION

    Important: Read all product information before using. Keep this box for important information.

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Use

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day 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.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have liver disease

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

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see overdose warning)
      adults and children 12 years and over
      • take 2 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets in 24 hours, unless directed by a doctor
      • do not use for more than 10 days unless directed by a doctor
    • children under 12 years, ask a doctor
  • Other information

    • store between 20-25˚C (68-77˚F)
    • do not use if pouch is torn or open
    • see side panel for lot number and expiration date
  • Inactive ingredients

    carnauba wax*, castor oil*, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

    • contains one or more of these ingredients
  • Questions or comments?

    1-800-570-8650

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Box

    See New Warnings Information & Directions

    Compate to the Active Ingredients in
    Tylenol® Extra Strength *

    ConRx™

    EXTRA
    STRENGTH

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
    Acetaminophen
    Pain Reliever - Fever Reducer

    PRINCIPAL DISPLAY PANEL - 50 Pouch Box
  • INGREDIENTS AND APPEARANCE
    CONRX EXTRA STRENGTH 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-233
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScore2 pieces
    ShapeOVALSize18mm
    FlavorImprint Code CRX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-233-1750 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/15/2013
    Labeler - Eagle Distributors,Inc. (929837425)
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