TYLENOL Extra Strength ACETAMINOPHEN KENVUE BRANDS LLC FDA Approved Uses temporarily relieves minor aches and pains due to: ​■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Acetaminophen 500 mg
Inactive Ingredients
Inactive ingredients FD&C red no. 40 FD&C yellow no. 6 gelatin glycerin hypromellose lecithin medium chain triglycerides polyethylene glycol povidone propylene glycol sorbitol titanium dioxide
Strengths
500 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To The Common Cold Headache Backache Minor Pain Of Arthritis Toothache Muscular Aches Premenstrual And Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: red Imprint: TY;500

Identifiers & Packaging

Container Type UNKNOWN
UPC
0300450439185
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 50580-469-18 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever - Fever Reducer LIQUID GELS Actual Size 18 Liquid Gels* 500 mg each *Liquid Filled Capsules tylenol-1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50580-469-18 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever - Fever Reducer LIQUID GELS Actual Size 18 Liquid Gels* 500 mg each *Liquid Filled Capsules tylenol-1

Overview

Uses temporarily relieves minor aches and pains due to: ​■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: ​■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 capsules every 6 hours while symptoms last do not take more than 6 capsules 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

Warnings & Precautions
Warnings 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.
Purpose

Purpose Pain reliever/fever reducer

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

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.

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information store between 20-25°C (68-77°F) do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing

Questions

Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


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