Tylenol Extra Strength Caplet ACETAMINOPHEN JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC 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 menstual cramps • temporarily reduces lever
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 500 mg Purpose Pain reliever/fever reducer
Inactive Ingredients
Inactive ingredients carnauba wax* corn starch* FD&C red no.40 aluminum lake hypromellose magnesium stearate modified starch* polyethylene glycol* powdered cellulose pregelatinized starch propylene glycol shellac sodium starch glycolate titanium dioxide * contains one or more of these ingredients
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 Menstual Cramps Temporarily Reduces Lever
Pill Appearance
Shape: oval Color: white Imprint: TYLENOL500

Identifiers & Packaging

Container Type UNKNOWN
UPC
0300450449108
UNII
362O9ITL9D
Packaging

Package Labeling: Pouch Label

Package Descriptions
  • Package Labeling: Pouch Label

Overview

Uses • temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstual cramps • temporarily reduces lever

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 menstual cramps • temporarily reduces lever

Dosage & Administration

Directions do not take more than directed (see overdose warning). Adults and children 12 years and over: take 2 capletes every 6 hours while symptoms last do not take more than 6 capletes 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 This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours Liver warning: 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 warnings: 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.

Questions

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


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