Drug Facts
EXTRA STRENGTH TYLENOL COLD Plus FLU MULTI-SYMPTOM DAY
EXTRA STRENGTH TYLENOL COLD + FLU MULTI-SYMPTOM NIGHT
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Extra Strength Tylenol Cold Plus Flu Multi-symptom Day Night (NDC 50580-585). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, uses, warnings, liver warning, other, sore throat warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
EXTRA STRENGTH TYLENOL COLD Plus FLU MULTI-SYMPTOM DAY
EXTRA STRENGTH TYLENOL COLD + FLU MULTI-SYMPTOM NIGHT
Active ingredients (in each caplet)
Active ingredients (in each caplet)
| Active ingredients (in each caplet) | Purpose |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Active ingredient (in each capsule) | Purpose |
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Dextromethorphan HBr 15 mg | Cough suppressant |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ temporarily reduces fever
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ sneezing and runny nose
■ temporarily reduces fever
Warnings
Warnings
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
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: ccetaminophen 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.
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.
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.
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
■ 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
■ persistent or chronic cough such as occurs with smoking, asthma or emphysema
■ cough that occurs with too much phlegm (mucus)
■ 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
When using this product do not exceed recommended dose
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.
■ 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.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
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.
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.
| adults and children 12 years
and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets 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 |
| adults and children
12 years and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets 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 |
■ store between 20-25°C (68-77°F)
■
do not use if blister unit is torn or broken
■ store between 20 - 25°C (68 - 77°F)
■
do not use if blister unit is torn or broken
carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide
carnauba wax, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
■ 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
NDC 50580-585-01
Extra Strength
TYLENOL®
FOR ADULTS
COLD + FLU
MULTI-SYMPTOM
Acetaminophen,
Dextromethorphan HBr
Pain Reliever–Fever Reducer,
Cough Suppressant
DAY
• HEAD + BODY ACHES
• FEVER
• SORE THROAT
• COUGH
Actual Size
16 CAPLETS
Acetaminophen,
Chlorpheniramine Maleate,
Dextromethorphan HBr
Pain Reliever-Fever Reducer,
Antihistamine, Cough Suppressant
NIGHT
• HEAD + BODY ACHES
• FEVER • SORE THROAT
• COUGH
• RUNNY NOSE
Actual Size
8 CAPLETS
TOTAL 24 CAPLETS
* Please review the disclaimer below.