Other
Drug Facts
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 Day (NDC 50580-140). 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, active ingredients(in each 30 ml), purpose, uses, liver warning, allergy alert, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Acetaminophen 1,000 mg
Dextromethorphan HBr 30 mg
Pain reliever/fever reducer
Cough suppressant
This product contains acetaminophen. Severe liver damage may occur if you take
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.
acetaminophen, ask a doctor or pharmacist.
taking the blood thinning drug warfarin
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 | ask a doctor |
“TYLENOL” is broken or missing
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)
* Please review the disclaimer below.