PHYSICIANSCARE COLD AND COUGH NON-DROWSY- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated
Acme United Corporation
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.
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Acetaminophen 325 mg
Dextromethorphan Hydrobromide 15 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Temporarily relieves these cold symptoms
■ cough
■ sore throat
■ minor aches and pains
■ headache
■ nasal congestion
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Temporarily reduces fever.
Liver warning: This product contains acetaminophen. 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
■ 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 have ever had an allergic reaction to this product or any of its ingredients
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If
you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
product.
■ liver disease
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
Adults and children: (12 years and older)
Take 2 tablets with water every 6-8 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12
Do not give to children under 12 years of age
■ store at room temperature 59º-86ºF (15º-30ºC)
■ avoid excessive heat and humidity
■ tamper evident sealed packets
■ do not use any opened or torn packets
PHYSICIANSCARE COLD AND COUGH
NON-DROWSY
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated |
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Labeler - Acme United Corporation (001180207) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Prestige Packaging | 170837962 | repack(0924-0140) , relabel(0924-0140) |