51b11ee1-f881-4e12-8298-6994414ce0f7
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
How Supplied
Product: 50090-2957 NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE
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, facial swelling, shock, asthmaaa9wheezing)
Stomach bleeding warning: This product contains an 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 prescription or nonprescription NSAIDs (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.
Indications and Usage
Use for the temporary relief of minor aches and pains due to:
headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor
Dosage and Administration
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
How Supplied
Product: 50090-2957
NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE
Description
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Section 44425-7
- store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
- use by expiration date on package
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
- you experience any of the following signs of stomach bleeding
-
- feel faint
- have bloody or black stools
- vomit blood
- have 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
- 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
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have not been drinking fluids
Section 50570-1
- if you are allergic to aspirin or any other pain reliever/fever reducer
Section 51727-6
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 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
Pain Reliever
Section 55106-9
In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug
Aspirin
Structured Label Content
Indications and Usage (34067-9)
Use for the temporary relief of minor aches and pains due to:
headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor
Dosage and Administration (34068-7)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult 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, facial swelling, shock, asthmaaa9wheezing)
Stomach bleeding warning: This product contains an 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 prescription or nonprescription NSAIDs (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.
Section 44425-7 (44425-7)
- store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
- use by expiration date on package
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)
- you experience any of the following signs of stomach bleeding
-
- feel faint
- have bloody or black stools
- vomit blood
- have 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)
- 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)
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have not been drinking fluids
Section 50570-1 (50570-1)
- if you are allergic to aspirin or any other pain reliever/fever reducer
Section 51727-6 (51727-6)
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 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)
Pain Reliever
Section 55106-9 (55106-9)
In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug
Aspirin
How Supplied (HOW SUPPLIED)
Product: 50090-2957
NDC: 50090-2957-0 1 TABLET, DELAYED RELEASE in a BLISTER PACK / 50 in a BOX, UNIT-DOSE
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Source: dailymed · Ingested: 2026-02-15T12:02:21.408844 · Updated: 2026-03-14T23:01:50.647319