Other
Drug Facts
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.
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 Daytime (NDC 50580-213). 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 other, otc - purpose, uses, warnings, liver warning, 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Active ingredients (in each 30 mL) | Purpose |
| Acetaminophen 1000 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take
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.
If pregnant or breast-feeding, ask a health professional before use.
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.
adults and children 12 years and over |
|
children under 12 years |
|
anhydrous citric acid, carboxymethylcellulose sodium, FD&C red no 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, poloxamer, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
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