TYLENOL Cold Plus Flu
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride · Tablet, Film Coated · Oral
Active ingredient
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
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
Uses
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
Warnings
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.
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 ) 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
Other information
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
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
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 1, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 4 products
- Dextromethorphan Hydrobromide in 4 products
- Guaifenesin in 4 products
- Phenylephrine Hydrochloride in 4 products
TYLENOL Cold Plus Flu NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-402 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 53209-1003 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Morning Star OTC | OTC MONOGRAPH DRUG |
| 67751-240 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Navajo Manufacturing Company Inc. | OTC MONOGRAPH DRUG |
| 85237-1956 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Select Consumer Group | OTC MONOGRAPH DRUG |
Frequently asked questions
What is TYLENOL Cold Plus Flu used for?
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
Who makes TYLENOL Cold Plus Flu?
TYLENOL Cold Plus Flu is listed by 4 labelers in the FDA NDC directory, including Kenvue Brands LLC, Morning Star OTC, Navajo Manufacturing Company Inc., Select Consumer Group.