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Generic: acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci is used for the treatment of Cough Urinary Bladder Neck Obstruction Duodenal Obstruction Infant, Newborn Infant, Premature Peptic Ulcer Prostatic Hyperplasia Rhinitis, Allergic, Perennial Status Asthmaticus Urticaria Glaucoma, Angle-Closure Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: AZ319     SHAPE: oval
    COLOR: blue

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Active Ingredient


Acetaminophen 325 mgChlorpheniramine maleate 2 mgDextromethorphan HBr 10 mgPhenylephrine HCI 5 mg

Purpose


Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant

Uses


temporarily relieves these common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • sneezing and runny nose
  • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever

Warnings


Liver warning/Allergy alert


Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets

(3,250 mg acetaminophen) 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
  • with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash 

If a skin reaction occurs, stop use and seek medical help immediately

Sore throat warning


Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, orParkinson’s disease), or for 2 weeks after stopping the MAOI drug. Ifyou do not know if your prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin 
  • taking sedatives or tranquilizers

When using this product


do not exceed recommended dosage.
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occurs
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts

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: In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. 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 Warnings)

Adults and children 12 years and over:
  • take 2 caplets every 4 hours
  • swallow whole; do not crush, chew or dissolve
  • do not take more than a total of 10 caplets in 24 hours

Children under 12 years: ask a doctor

Other Information

  • store at room temperature 20°– 25°C (68°– 77°F)
  • do not use if buler is torn or open

Inactive Ingredients


corn starch, crospovidone, croscarmellosesodium, FD&C blue #1 aluminum lake, hypromellose, magnesiumstearate, microcrystalline cellulose, povidone, pregelatinized starch,polyethylene glycol, silicon dioxide, stearic acid, itanium dioxide

May contain: FD&C lake black

Questions Or Comments?


Call toll free 1-888-952-0050 Monday through Friday 

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DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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