Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, and caffeine capsule, coated
- NDC Code(s): 73598-1372-1
- Packager: JHK Inc dba American Safety & First Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- ACTIVE INGREDIENT
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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
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
- Directions Adults
- Other Information
- Inactive ingredient
- Questions?
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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 RelieverPain 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
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin, and caffeine capsule, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73598-1372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape RECTANGLE Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73598-1372-1 25 in 1 BOX 02/02/2000 1 2 in 1 DOSE PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M013 02/02/2000 Labeler - JHK Inc dba American Safety & First Aid (867236309)