Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 50580-243-01 EXTRA STRENGTH TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT NEW! DOSAGE + DIRECTIONS Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine HEAD + BODY ACHES FEVER + SORE THROAT COUGH NIGHT FROSTED BERRY 8 fl oz (240 mL) tylenol-1
- PRINCIPAL DISPLAY PANEL NDC 50580-243-01 EXTRA STRENGTH TYLENOL ® FOR ADULTS SEVERE COUGH + SORE THROAT NEW! DOSAGE + DIRECTIONS Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine HEAD + BODY ACHES FEVER + SORE THROAT COUGH NIGHT FROSTED BERRY 8 fl oz (240 mL) tylenol-1
Overview
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough sneezing and runny nose temporarily reduces fever
Indications & Usage
Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough sneezing and runny nose temporarily reduces fever
Dosage & Administration
Directions do not take more than directed (see overdose warning ) shake well before using mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Warnings & Precautions
Warnings 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. Do not use 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 Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma 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 dose 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 pain 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 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.
Purpose
Active ingredients (in each 30 mL) Purpose Acetaminophen 1,000 mg Pain reliever/fever reducer Dextromethorphan HBr 30 mg Cough suppressant Doxylamine Succinate 12.5 mg Antihistamine
Do Not Use
Do not use 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
When Using
When using this product do not exceed recommended dose 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 & Ask a Doctor
Stop use and ask a doctor if pain 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.
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information each 30 mL contains: sodium 19 mg store between 20-25°C (68-77°F) do not use if neck band imprinted with "INSTANT COOLING SENSATION" or foil inner seal imprinted with "TYLENOL" is broken or missing
Questions
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
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