TYLENOL Cold Head Congestion Severe
Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-566
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.
COLD + HEAD CONGESTION SEVERE
|Active ingredients (in each caplet)||Purpose|
|Acetaminophen 325 mg||Pain reliever/fever reducer|
|Guaifenesin 200 mg||Expectorant|
|Phenylephrine HCl 5 mg||Nasal decongestant|
- for the temporary relief of the following cold symptoms:
- minor aches and pains
- sore throat
- nasal congestion
- sinus congestion and pressure
- 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 or blister unit is opened or broken
carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
See New Warning
COLD + HEAD
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant
- HEADACHE + BODY ACHES
- FEVER + SORE THROAT
- NASAL CONGESTION
- MUCUS + CHEST CONGESTION
HEAD CONGESTION SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
|Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.