Extra Strength Pain Reliever Capsule, Coated
FDA Label NDC 73598-1372

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jhk Inc Dba American Safety & First Aid for the product Extra Strength Pain Reliever (NDC 73598-1372). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

Active ingredient (In Each Caplets)Purpose
Acetaminophen 250 mgpain reliever/fever reducer
Aspirin 250 mg (NSAID)

Nonsteroidal Anti-Inflammatory Drug

pain reliever/fever reducer
Caffeine 65 mgpain reliever aid

Use

temporarily relieves fever and minor aches and pains associated with:

  • headache
  • colds
  • muscular aches
  • menstrual discomfort
  • toothaches
  • minor arthritis pain

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • anticoagulation (thinning of blood)
  • diabetes
  • gout
  • arthritis

Otc - When Using

When using this product do not exceed recommended dose.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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.

Otc - 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.

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.

Other Information

  • do not use if packet is opened or torn
  • store at room temperature 68°-77°F (20°-25°C)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg

Inactive Ingredient

Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc

Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

Manufactured for American Safety & First Aid Osceola, IN 46561

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)

    Principal Display Panel (50 Caplet Packet Box)

* Please review the disclaimer below.