Childrens TYLENOL ACETAMINOPHEN KENVUE BRANDS LLC FDA Approved Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache 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 chewable tablet) Acetaminophen 160 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid cellulose acetate crospovidone D&C red no. 7 calcium lake dextrose flavor magnesium stearate povidone sucralose
Strengths
160 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To The Common Cold Flu Headache Sore Throat Toothache Temporarily Reduces Fever
Pill Appearance
Shape: round Color: pink Imprint: TY;160;HALF;HALF

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0300450519245
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 50580-521-24 Children's TYLENOL ® Acetaminophen Pain Reliever Fever Reducer Ibuprofen Free Aspirin Free Pain+Fever Ages 2-11 Chewables Chew or crush tablets completely before swallowing 160 mg Per Tablet 24 Chewable Tablets 160 mg each Actual Size Bubble Gum Flavor tylenol-1

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50580-521-24 Children's TYLENOL ® Acetaminophen Pain Reliever Fever Reducer Ibuprofen Free Aspirin Free Pain+Fever Ages 2-11 Chewables Chew or crush tablets completely before swallowing 160 mg Per Tablet 24 Chewable Tablets 160 mg each Actual Size Bubble Gum Flavor tylenol-1

Overview

Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever

Dosage & Administration

Directions this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets) or as directed by a doctor under 24 under 2 years ask a doctor 24-35 2-3 years 1 tablet 36-47 4-5 years 1½ tablets 48-59 6-8 years 2 tablets 60-71 9-10 years 2½ tablets 72-95 11 years 3 tablets

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is 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 5 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. 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 your child is 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 5 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). Avoid high humidity. Protect from light. do not use if foil inner seal imprinted with "TYLENOL" is broken or missing

Questions

Questions or comments? call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)


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