TYLENOL Cold Plus Flu Severe by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Medically reviewed on October 26, 2017
Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-402
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.
|Active ingredients (in each caplet)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Dextromethorphan HBr 10 mg||Cough suppressant|
|Guaifenesin 200 mg||Expectorant|
|Phenylephrine HCl 5 mg||Nasal decongestant|
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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
If a skin reaction occurs, stop use and seek medical help right away.
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
- 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)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|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 carton is opened or if blister unit is broken
carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
COLD + FLU SEVERE
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant
- HEAD + BODY ACHES
- FEVER + SORE THROAT
- NASAL CONGESTION
- MUCUS + CHEST CONGESTION
|TYLENOL COLD PLUS FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
|Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)|
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- Drug class: upper respiratory combinations
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