TYLENOL Cold Plus Flu Severe ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE KENVUE BRANDS LLC FDA Approved Uses 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

Drug Facts

Composition & Profile

Active Ingredients
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
Inactive Ingredients
Inactive ingredients 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
Strengths
325 mg 10 mg 200 mg 5 mg
Treats Conditions
Uses 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
Pill Appearance
Shape: oval Color: yellow Imprint: TYLENOL;SEVERE

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL NDC 50580-402-26 TYLENOL ® FOR ADULTS COLD + FLU SEVERE Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant HEAD + BODY ACHES FEVER + SORE THROAT COUGH NASAL CONGESTION MUCUS + CHEST CONGESTION Actual Size 24 CAPLETS PRINCIPAL DISPLAY PANEL

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50580-402-26 TYLENOL ® FOR ADULTS COLD + FLU SEVERE Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant HEAD + BODY ACHES FEVER + SORE THROAT COUGH NASAL CONGESTION MUCUS + CHEST CONGESTION Actual Size 24 CAPLETS PRINCIPAL DISPLAY PANEL

Overview

Uses 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

Indications & Usage

Uses 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

Dosage & Administration

Directions 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

Warnings & Precautions
Warnings 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. 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 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) 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 Stop use and ask a doctor if 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.
Purpose

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

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

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if blister unit is torn or broken

Questions

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


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