Tylenol Cold + Flu Severe
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division for the product Tylenol Cold Max (NDC 50580-571). 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 tylenol cold + flu severe, otc - purpose, uses, liver warning, other, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredients (in each 15 mL) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
| Active ingredients (in each 15 mL) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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
These could be signs of a serious condition.
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 |
|
| children under 12 years | ask a doctor |
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
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
alcohol, anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
Drug Facts
NDC 50580-241-01
DAYTIME
TYLENOL®
FOR ADULTS
COLD + FLU SEVERE
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant
Warming
HONEY
LEMON
8 fl oz (240 mL)
NIGHTTIME
TYLENOL®
FOR ADULTS
COLD MAX
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine, Nasal Decongestant
COOL
BURST®
Alcohol 0.5%
8 fl oz (240 mL)
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