FDA Label for Conrx Pain Reliever

View Indications, Usage & Precautions

Conrx Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Eagle Distributors,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each tablet)Purposes
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID)

nonsteroidal anti-inflammatory drug

Pain reliever
Caffeine 65 mgPain reliever aid

Uses



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

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

Otc - Ask Doctor/Pharmacist



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

Otc - Pregnancy Or Breast Feeding



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.


Otc - Keep Out Of Reach Of Children



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.


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

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.

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


Questions Or Comments?



1-800-570-8650


Principal Display Panel - 50 Pouch Box



See New Warnings Information & Directions

Compare to the Active Ingredients in
EXCERDRIN*
®

ConRx™

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


* Please review the disclaimer below.