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 Morning Star Otc for the product Tylenol Pm (NDC 53209-1002). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, 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 caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever |
| Diphenhydramine HCl 25 mg | Nighttime sleep aid |
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
This product contains acetaminophen. Severe liver damage may occur if you take
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 | do not use |
carnauba wax, crospovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
call 1-877-895-3665(toll-free) or 215-273-8755(collect)
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