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 Childrens Tylenol (NDC 50580-299). 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 your child has, ask a doctor or pharmacist before use if your child is, 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 5 mL) | Purpose |
|---|---|
| Acetaminophen 160 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 1 mg | Antihistamine |
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if your child takes
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.
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.
| Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
|---|---|---|
| under 36 | under 4 years | do not use |
| 36-47 | 4 to 5 years | do not use unless directed by a doctor |
| 48-95 | 6 to 11 years | 10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)
NDC 50580-299-01
Children's
TYLENOL®
COLD +
FLU
Acetaminophen, Pain Reliever-Fever Reducer
Chlorpheniramine Maleate, Antihistamine
Dextromethorphan HBr, Cough Suppressant
Phenylephrine HCl, Nasal Decongestant
Oral Suspension
Ages 6-11 Years
Grape
Flavor
4 fl oz (120 mL)
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