TYLENOL Regular 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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 325 mg
Inactive Ingredients
Inactive ingredients carnauba wax hypromellose magnesium stearate powdered cellulose pregelatinized starch sodium starch glycolate
Strengths
325 mg
Quantities
10 count
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
Shape: oval Color: white Imprint: TYLENOL;325

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL 325 mg NDC 50580-475-11 To re-order reference the NDC Code TYLENOL® Acetaminophen Pain Reliever - Fever Reducer Regular Strength FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT. 100 Caplets 325 mg each 10 Blister Cards with 10 Individual Blisters SMART PACKAGING DESIGNED FOR HEALTH CARE PROFESSIONALS tylenol-1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL 325 mg NDC 50580-475-11 To re-order reference the NDC Code TYLENOL® Acetaminophen Pain Reliever - Fever Reducer Regular Strength FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT. 100 Caplets 325 mg each 10 Blister Cards with 10 Individual Blisters SMART PACKAGING DESIGNED FOR HEALTH CARE PROFESSIONALS 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) adults and children 12 years and over ■ take 2 caplets every 4 to 6 hours while symptoms last ■ do not take more than 10 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years ■ take 1 caplet every 4 to 6 hours while symptoms last ■ do not take more than 5 caplets in 24 hours ■ do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

Warnings & Precautions
Warnings Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if ■ adult takes more than 4,000 mg of acetaminophen in 24 hours ■ child takes more than 5 doses in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 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 the user ■ has liver disease ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days in adults ■ pain gets worse or lasts more than 5 days in children under 12 years ■ 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 in adults ■ pain gets worse or lasts more than 5 days in children under 12 years ■ 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 blister unit is torn or broken

Questions

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


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