TYLENOL PM- acetaminophen, diphenhydramine hydrochloride tablet, film coated
Savings Distributors LLC
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.
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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
■ glaucoma
■ 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 ■ take 2 caplets at bedtime
12 years and over ■ do not take more than 2 caplets of
this product in 24 hours
children under 12 years do not use
TYLENOL PM
acetaminophen, diphenhydramine hydrochloride tablet, film coated |
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Labeler - Savings Distributors LLC (010527359) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Savings Distributors LLC | 010527359 | repack(73097-013) |