Extra Strength Pain Reliever
87c5ad71-0448-4e0f-acee-bf9a1d38675e
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Description
Drug Facts
Use
temporarily relieves fever and minor aches and pains associated with:
- headache
- colds
- muscular aches
- menstrual discomfort
- toothaches
- minor arthritis pain
Section 42229-5
Drug Facts
Section 50565-1
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.
Section 50566-9
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
Section 50567-7
When using this product do not exceed recommended dose.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- anticoagulation (thinning of blood)
- diabetes
- gout
- arthritis
Section 53414-9
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.
Section 55105-1
| 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
- 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.
Questions?
1-866-651-3660 Monday-Friday
8:00am-5:00pm EST
Manufactured for American Safety & First Aid Osceola, IN 46561
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
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.
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.
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 68º-77ºF (20º-25ºC)
- 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
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
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
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
Structured Label Content
Use
temporarily relieves fever and minor aches and pains associated with:
- headache
- colds
- muscular aches
- menstrual discomfort
- toothaches
- minor arthritis pain
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product do not exceed recommended dose.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- anticoagulation (thinning of blood)
- diabetes
- gout
- arthritis
Section 53414-9 (53414-9)
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.
Section 55105-1 (55105-1)
| 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.
Questions?
1-866-651-3660 Monday-Friday
8:00am-5:00pm EST
Manufactured for American Safety & First Aid Osceola, IN 46561
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
Reye's Syndrome (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.
Caffeine Warning (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.
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 68º-77ºF (20º-25ºC)
- avoid excessive heat and humidity
- each caplet contains: Magnesium 0.58 mg
Inactive Ingredient (Inactive ingredient)
Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc
Ask Doctor Before Use If (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
Stomach Bleeding Warning (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
Principal Display Panel 50 Caplet Packet Box (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:00.772156 · Updated: 2026-03-14T23:02:50.389879