Tylenol PM Extra Strength
Dosage form: tablet, coated
Ingredients: Acetaminophen 500mg, Diphenhydramine Hydrochloride 25mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-176
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.
|Active ingredients (in each geltab)||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
- 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
- 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. 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.
- do not take more than directed (see overdose warning)
|adults and children 12 years and over||
|children under 12 years||do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage|
- store between 20-25°C (68-77°F). Avoid high humidity.
- do not use if carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
- see end panel for lot number and expiration date
benzyl alcohol, butylparaben, castor oil, D&C red #28, edetate calcium disodium, FD&C blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, shellac, simethicone, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide
acetaminophen and diphenhydramine hydrochloride tablet, coated
|Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.