TYLENOL Extra Strength ACETAMINOPHEN KENVUE BRANDS LLC FDA Approved 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
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 30 mL) Acetaminophen 960 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid flavors glycerin microcrystalline cellulose and carboxymethylcellulose sodium potassium sorbate purified water sorbitol solution sucralose sucrose xanthan gum
Strengths
30 ml 960 mg
Quantities
30 ml 240 ml
Treats Conditions
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
Pill Appearance
Color: white

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0300450420084
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 50580-187-08 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen (960 mg per 30 mL) Oral Suspension Pain Reliever-Fever Reducer Adult Liquid Pain Reliever Dye-Free Alcohol Free 8 fl oz (240 mL) 960 mg per 30 mL Cherry Flavor tylenol-1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50580-187-08 NEW Extra Strength TYLENOL ® FOR ADULTS Acetaminophen (960 mg per 30 mL) Oral Suspension Pain Reliever-Fever Reducer Adult Liquid Pain Reliever Dye-Free Alcohol Free 8 fl oz (240 mL) 960 mg per 30 mL Cherry Flavor 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

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

Dosage & Administration

Directions ■ do not take more than directed (see overdose warning) ■ shake well before using ■ remove child protective cap ■ squeeze the dose into the dosing cup ■ mL = milliliter​ adults and children 12 years and over ■ take 30 mL (2 x 15 mL) every 6 hours while symptoms last. For dosing, the dosing cup needs to be filled to 15 mL line twice. ■ do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

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 When using this product do not exceed recommended dose (see overdose warning ) 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 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

When Using

When using this product do not exceed recommended dose (see overdose warning )

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 ■ each 30 mL contains: potassium 30 mg ■ store between 20-25°C (68-77°F) ■ do not use if carton is opened. Do not use if bottle wrap 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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