Label: CONRX PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet 

  • Label RSS
  • NDC Code(s): 68737-234-18
  • Packager: Eagle Distributors,Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes
    *
    nonsteroidal anti-inflammatory drug
    Acetaminophen 250 mg Pain reliever
    Aspirin 250 mg (NSAID)* Pain reliever
    Caffeine 65 mg Pain reliever aid
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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • a cold
      • arthritis
      • muscular aches
      • sinusitis
      • toothache
      • premenstrual & menstrual cramps
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  • Warnings

    Reye's syndrome

    Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Liver warning

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

    • adult takes more than 8 tablets in 24 hours, which is the maximum daily amount
    • child takes more than 5 tablets in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning

    This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Caffeine warning

    The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

    Do not use

    • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    • 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

    • you have liver disease
    • stomach bleeding warning applies to you
    • you have not been drinking fluids
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma
    • you have lost a lot of fluids due to vomiting or diarrhea

    Ask a doctor or pharmacist before use if you are taking

    • any other drug containing an NSAID (prescription or nonprescription)
    • a blood thinning (anticoagulant) or steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor's care for any serious condition

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
      • ringing in the ears or loss of hearing occurs
      • painful area is red or swollen
      • pain gets worse or lasts for more than 10 days
      • fever gets worse or lasts for more than 3 days
      • any new symptoms appear

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
    • children under 12 years: ask a doctor
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  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • read all product information before using. Keep this box for important information.
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  • Inactive ingredients

    benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-570-8650

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  • PRINCIPAL DISPLAY PANEL - 50 Pouch Box

    See New Warnings Information & Directions

    Compare to the Active Ingredients in
    EXCERDRIN*
    ®

    ConRxâ„¢

    EXTRA
    STRENGTH

    PAIN RELIEVER

    Acetaminophen, Asprin (NSAID) and Caffeine

    TO OPEN
    PUSH IN TAB AND PULL OUT

    Compare to the Active Ingredients in
    EXCEDRIN*
    ®

    50 Pouches of 2 Caplets Each

    Principal Display Panel - 50 Pouch Box
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  • INGREDIENTS AND APPEARANCE
    CONRX PAIN RELIEVER 
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68737-234
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 250 mg
    Aspirin (Aspirin) Aspirin 250 mg
    Caffeine (Caffeine) Caffeine 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    BENZOIC ACID  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    FD&C BLUE NO. 1  
    HYPROMELLOSES  
    LIGHT MINERAL OIL  
    CELLULOSE, MICROCRYSTALLINE  
    POLYSORBATE 20  
    POVIDONES  
    POLYETHYLENE GLYCOL 6000  
    DIMETHICONE  
    SORBITAN MONOLAURATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 18mm
    Flavor Imprint Code CRX
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68737-234-18 50 in 1 BOX
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 02/15/2013
    Labeler - Eagle Distributors,Inc. (929837425)
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