Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 50580-142-01 Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever Fever Reducer RAPID RELEASE GELS Actual Size 225 Gelcaps* 500 mg each *Gelatin-Coated Tablets + FREE BONUS ITEM TYLENOL ® PRECISE TM Cooling † Pain Relieving Cream Lidocaine 4% Menthol 1% Fast acting † Targeted penetrating pain relief Maximum Strength Lidocaine without a prescription LIGHTLY SCENTED For external use only NET WT. 0.5 OZ (14.2 g) tylenol-1
- PRINCIPAL DISPLAY PANEL NDC 50580-142-01 Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever Fever Reducer RAPID RELEASE GELS Actual Size 225 Gelcaps* 500 mg each *Gelatin-Coated Tablets + FREE BONUS ITEM TYLENOL ® PRECISE TM Cooling † Pain Relieving Cream Lidocaine 4% Menthol 1% Fast acting † Targeted penetrating pain relief Maximum Strength Lidocaine without a prescription LIGHTLY SCENTED For external use only NET WT. 0.5 OZ (14.2 g) tylenol-1
Overview
Uses ■ temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps ■ temporarily reduces fever Uses For the temporary relief of pain
Indications & Usage
Uses ■ temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps ■ temporarily reduces fever Uses For the temporary relief of pain
Dosage & Administration
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor Directions ■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor
Warnings & Precautions
Warnings 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. Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present 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. Overdose warning 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. Warnings For external use only. Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas When using this product ▪ avoid contact with eyes Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days ▪ symptoms clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Pain reliever/fever reducer Purpose Topical analgesic Topical analgesic
Do Not Use
Do not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product
When Using
Do not use ▪ in large quantities, particularly over raw surfaces or blistered areas When using this product ▪ avoid contact with eyes
Stop Use & Ask a Doctor
Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present These could be signs of a serious condition. Stop use and ask a doctor if ▪ condition worsens or symptoms persist for more than 7 days ▪ symptoms clear up and occur again within a few days
Keep Out of Reach of Children
Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information ■ store between 20-25°C (68-77°F). Avoid high humidity. ■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing. Other Information store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)
Questions
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) Questions? Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.