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 Severe Cough Plus Sore Throat Night (NDC 50580-243). 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, liver warning, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 1,000 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine Succinate 12.5 mg | Antihistamine |
temporarily relieves these common cold/flu symptoms:
temporarily reduces fever
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.
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 | ask a doctor |
anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, 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)
NDC 50580-243-01
EXTRA STRENGTH TYLENOL ®
FOR ADULTS
SEVERE COUGH + SORE THROAT
NEW!
DOSAGE + DIRECTIONS
Acetaminophen,
1,000 mg / 30 mL
Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine
NIGHT
FROSTED BERRY
8 fl oz (240 mL)
* Please review the disclaimer below.