TYLENOL COLD PLUS FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated
Savings Distributors LLC
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 HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
■ for the temporary relief of the following cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ cough
■ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
■ temporarily reduces fever
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
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 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.
■ if you have ever had an allergic reaction to this product or any of its ingredients.
■ 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, chronic bronchitis or emphysema
■ cough that occurs with too much phlegm (mucus)
■ nervousness, dizziness, or sleeplessness occur
■ 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.
■ do not take more than directed (see overdose warning)
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 10 caplets in 24 hours
children under 12 years ask a doctor
■ each caplet contains: sodium 3 mg
■ store between 20-25°C (68-77°F)
■ do not use if pouch is torn or damaged
TYLENOL COLD PLUS FLU SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated |
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Labeler - Savings Distributors LLC (010527359) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Savings Distributors LLC | 010527359 | repack(73097-011) |