Tylenol Cold Plus Flu Severe
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant
Purpose
Active ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant
Uses
Uses temporarily relieves 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
Warnings
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 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. 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.
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
Ask a doctor before use
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product
When using this product do not exceed recommended dose
Stop use and 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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Directions
Directions do not take more than directed (see overdose warning ) 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 4 hours while symptoms last do not take more than 150 mL in 24 hours, unless directed by a doctor children under 12 years ask a doctor
Other information
Other information each 30 mL contains: sodium 10 mg store between 20-25°C (68-77°F). do not use if neck band imprinted with "WARMING SENSATION" or foil inner seal imprinted with "TYLENOL" is broken or missing
Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions?
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised Nov 7, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 3 products
- Dextromethorphan Hydrobromide in 3 products
- Guaifenesin in 3 products
- Phenylephrine Hydrochloride in 3 products
Tylenol Cold Plus Flu Severe NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 67414-402 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Jones Healthcare Group - Packaging Services, Inc | OTC MONOGRAPH DRUG |
| 50580-403 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Guaifenesin 400 mg/30mL; Phenylephrine… Solution | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 73097-011 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Savings Distributors LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Tylenol Cold Plus Flu Severe used for?
Uses temporarily relieves 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
Who makes Tylenol Cold Plus Flu Severe?
Tylenol Cold Plus Flu Severe is listed by 3 labelers in the FDA NDC directory, including Jones Healthcare Group - Packaging Services, Inc, Kenvue Brands LLC, Savings Distributors LLC.