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Drug Facts
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.
Drug Facts
| 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 |
temporarily relieves fever and minor aches and pains associated with:
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.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take:
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:
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.
Ask a doctor or pharmacist before use if you are taking a prescription drug for
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:
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.
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.
Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc
1-866-651-3660 Monday-Friday
8:00am-5:00pm EST
Manufactured for American Safety & First Aid Osceola, IN 46561
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
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
* Please review the disclaimer below.