Drug Facts
a0f84fac-3f7c-45c0-a2e8-ce39fb2bd630
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Medication Information
Warnings and 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
- shock
- facial swelling
- asthma (wheezing)
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
- has 3 or more alcoholic drinks every day while using this product
- is age 60 or older
Indications and Usage
Uses
temporarily relieves
- headache
- muscle pain
- menstrual pain
- toothache
- minor pain of arthritis
- pain and fever of colds
Dosage and Administration
Directions
DRINK A FULL GLASS OF WATER WITH EACH DOSE
- adults and children 12 years and over : 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
-
children under 12 years: ask a doctor
Description
Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Section 44425-7
Other information
- store at 20° - 25°C (68° - 77°F)
Section 50565-1
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and ask a doctor if
- user experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
Section 50568-5
Ask a doctor or pharmacist before use if user is
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
Section 50569-3
Ask a doctor before use if
- stomach bleeding warning applies to user
- user has a history of stomach problems such as heartburn
- user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
- user is taking a diuretic
- user has asthma
- user has not been drinking fluids
Section 50570-1
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer
Section 51727-6
Inactive ingredients
corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Section 53413-1
Questions or comments?
call
1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
Section 53414-9
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 55105-1
Purpose
Pain reliever
Section 55106-9
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Principal Display Panel
Structured Label Content
Indications and Usage (34067-9)
Uses
temporarily relieves
- headache
- muscle pain
- menstrual pain
- toothache
- minor pain of arthritis
- pain and fever of colds
Dosage and Administration (34068-7)
Directions
DRINK A FULL GLASS OF WATER WITH EACH DOSE
- adults and children 12 years and over : 1 - 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
-
children under 12 years: ask a doctor
Warnings and Precautions (34071-1)
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
- shock
- facial swelling
- asthma (wheezing)
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
- has 3 or more alcoholic drinks every day while using this product
- is age 60 or older
Section 44425-7 (44425-7)
Other information
- store at 20° - 25°C (68° - 77°F)
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.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- user experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if user is
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug
- under a doctor's care for any serious condition
Section 50569-3 (50569-3)
Ask a doctor before use if
- stomach bleeding warning applies to user
- user has a history of stomach problems such as heartburn
- user has high blood pressure, heart disease, liver cirrhosis, or kidney disease
- user is taking a diuretic
- user has asthma
- user has not been drinking fluids
Section 50570-1 (50570-1)
Do not use
if you have ever had an allergic reaction to any other pain reliever/fever reducer
Section 51727-6 (51727-6)
Inactive ingredients
corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Section 53413-1 (53413-1)
Questions or comments?
call
1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
Section 53414-9 (53414-9)
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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)
Purpose
Pain reliever
Section 55106-9 (55106-9)
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Principal Display Panel
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:26.511236 · Updated: 2026-03-14T22:53:04.035717