Extra Strength Pain Reliever ACETAMINOPHEN ASPIRIN AND CAFFEINE JHK INC DBA AMERICAN SAFETY & FIRST AID FDA Approved Use temporarily relieves fever and minor aches and pains associated with: headache colds muscular aches menstrual discomfort toothaches minor arthritis pain
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid
Inactive Ingredients
Inactive ingredient Colloidal Silicon Dioxide Hypromellose Microcrystalline Cellulose Polyvinyl Pyrrolidone Polyethylene Glycol Pregelatinized Starch Starch 1500 Stearic Acid Talc
Strengths
250 mg 65 mg
Treats Conditions
Use Temporarily Relieves Fever And Minor Aches And Pains Associated With Headache Colds Muscular Aches Menstrual Discomfort Toothaches Minor Arthritis Pain
Pill Appearance
Shape: rectangle Color: white Imprint: S53

Identifiers & Packaging

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

PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box This product is not manufactured or distributed by Novartis Owner of the registered trademark Excedrin ® . Product #1372 Extra Strength Pain Reliever Pain Reliever/Fever Reducer Active ingredient: Acetaminophen, Aspirin Caffeine Temporary relief from pain, fever, and inflammation Soothes muscle aches and minor arthritis pain These quality comfort caplets are formulated and packaged for use in the workplace and meet ANSI Z308. 1-2021 standards. They are sealed in tamper-evident packets for safety and convenience. 50 Caplets • 2 Caplets Per Packet PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box This product is not manufactured or distributed by Novartis Owner of the registered trademark Excedrin ® . Product #1372 Extra Strength Pain Reliever Pain Reliever/Fever Reducer Active ingredient: Acetaminophen, Aspirin Caffeine Temporary relief from pain, fever, and inflammation Soothes muscle aches and minor arthritis pain These quality comfort caplets are formulated and packaged for use in the workplace and meet ANSI Z308. 1-2021 standards. They are sealed in tamper-evident packets for safety and convenience. 50 Caplets • 2 Caplets Per Packet PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box

Overview

Use temporarily relieves fever and minor aches and pains associated with: headache colds muscular aches menstrual discomfort toothaches minor arthritis pain

Indications & Usage

Use temporarily relieves fever and minor aches and pains associated with: headache colds muscular aches menstrual discomfort toothaches minor arthritis pain

Dosage & Administration

Directions Adults 2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult 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 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 a nonsteroidal anti-inflammatory drug (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 a prescription or nonprescription NSAID (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 dosage of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and, occasionally, rapid heartbeat. Do not use if you are allergic to aspirin with any other pain reliever/fever reducer if you have ever had an allergic reaction to any other pain reliever/fever reducer for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask doctor before use if stomach bleeding warning applies to you you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease you are taking diuretic you have a history of stomach problems, such as heartburn Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood) diabetes gout arthritis When using this product do not exceed recommended dose. Stop use and ask doctor if 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 ringing in the ears or loss of hearing occurs pain or fever persists or gets worse New symptoms occur Redness or swelling is present If pregnant or breastfeeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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 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

Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid

Do Not Use

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

When Using

When using this product do not exceed recommended dose.

Stop Use & Ask a Doctor

Stop use and ask doctor if 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 ringing in the ears or loss of hearing occurs pain or fever persists or gets worse New symptoms occur Redness or swelling is present

Keep Out of Reach of Children

Keep out of reach of children. In case of 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.

Storage & Handling

Other Information do not use if packet is opened or torn store at room temperature 68º-77ºF (20º-25ºC) avoid excessive heat and humidity each caplet contains: Magnesium 0.58 mg

Questions

Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST Manufactured for American Safety & First Aid Osceola, IN 46561


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