TYLENOL PM- acetaminophen, diphenhydramine hydrochloride tablet, film coated
Navajo Manufacturing Company Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredients
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present • new symptoms occur These could be signs of a serious condition.
do not take more than directed (see overdose warning)
|adults and children 12 years and over||
• take 2 caplets at bedtime
• do not take more than 2 caplets of this product in 24 hours
|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
acetaminophen, diphenhydramine hydrochloride tablet, film coated
|Labeler - Navajo Manufacturing Company Inc. (091917799)|
|Navajo Manufacturing Company Inc.||136941411||relabel(67751-168) , repack(67751-168)|