Extra Pain Relief Acetaminophen, Aspirin (NSAID) and Caffeine ACETAMINOPHEN ASPIRIN CAFFEINE MEDLINE INDUSTRIES, LP FDA Approved Uses temporarily relieves minor aches and pains due to: headache sinusitis cold arthritis muscular aches toothache premenstual and menstrual cramps
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide hypromellose microcrystalline cellulose mineral oil povidone pregelatinized starch sodium starch glycolate stearic acid titanium dioxide
Strengths
250 mg 65 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Sinusitis Cold Arthritis Muscular Aches Toothache Premenstual And Menstrual Cramps
Pill Appearance
Shape: capsule Color: white Imprint: TCL370

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
Packaging

Package Label label

Package Descriptions
  • Package Label label

Overview

Uses temporarily relieves minor aches and pains due to: headache sinusitis cold arthritis muscular aches toothache premenstual and menstrual cramps

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache sinusitis cold arthritis muscular aches toothache premenstual and menstrual cramps

Dosage & Administration

Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: do not use unless directed by a doctor

Warnings & Precautions
Warnings Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine Warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine containing medications, foods or beverages which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor Ask doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma you have liver disease Stop using and ask a doctor if an allergic reaction occurs. Seek medical help right away. painful area is red or swollen symptoms do not improve any new symptoms appear pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product fever gets worse or lasts for more than 3 days pain gets worse or lasts for more than 10 days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 Pain reliever Pain reliever aid

Do Not Use

Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor

Stop Use & Ask a Doctor

Stop using and ask a doctor if an allergic reaction occurs. Seek medical help right away. painful area is red or swollen symptoms do not improve any new symptoms appear pain or fever persists or gets worse you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product fever gets worse or lasts for more than 3 days pain gets worse or lasts for more than 10 days

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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