Gc 983
0548591b-6cd2-4977-a346-fdf5bd04eead
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug
Medication Information
Warnings and Precautions
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
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
Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
-
•the stomach bleeding warning applies to you
-
•you are taking a diuretic
-
•you have a history of stomach problems, such as heartburn
-
•you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
Ask a doctor or pharmacist before use if you are
-
•taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a 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
-
•an allergic reaction occurs. Seek medical help right away
-
•pain gets worse or lasts more than 10 days
-
•redness or swelling is present
-
•fever gets worse or lasts more than 3 days
-
•any new symptoms occur
-
•ringing in the ears or loss of hearing occurs
These can be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Indications and Usage
-
•for the temporary relief of minor aches and pains
-
•ask your doctor about other uses for aspirin
Dosage and Administration
-
•drink a full glass of water with each dose
-
•swallow whole, do not chew or crush
-
•do not exceed recommended dose
-
•adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
-
•children under 12 years: ask a doctor
Description
Aspirin 81 mg(NSAID)* *nonsteroidal anti-inflammatory drug
Section 44425-7
-
•store at 20-25°C (68-77°F); excursions permitted between 15°C-30°C (59°F-86°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 51727-6
cellulose, croscarmellose sodium, D&C Yellow #10 Lake, lactose monohydrate, methacrylic acid co-polymer, PEG, polacrilin potassium, polyvinyl alcohol, silica, sodium lauryl sulfate, soya powder, talc, titanium dioxide, triethyl citrate
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8565-8
Section 51945-4
Section 53413-1
1-800-540-3765
Section 55105-1
Pain reliever
Section 55106-9
Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
Structured Label Content
Indications and Usage (34067-9)
-
•for the temporary relief of minor aches and pains
-
•ask your doctor about other uses for aspirin
Dosage and Administration (34068-7)
-
•drink a full glass of water with each dose
-
•swallow whole, do not chew or crush
-
•do not exceed recommended dose
-
•adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
-
•children under 12 years: ask a doctor
Warnings and Precautions (34071-1)
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
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
Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
-
•the stomach bleeding warning applies to you
-
•you are taking a diuretic
-
•you have a history of stomach problems, such as heartburn
-
•you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
Ask a doctor or pharmacist before use if you are
-
•taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a 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
-
•an allergic reaction occurs. Seek medical help right away
-
•pain gets worse or lasts more than 10 days
-
•redness or swelling is present
-
•fever gets worse or lasts more than 3 days
-
•any new symptoms occur
-
•ringing in the ears or loss of hearing occurs
These can be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 44425-7 (44425-7)
-
•store at 20-25°C (68-77°F); excursions permitted between 15°C-30°C (59°F-86°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 51727-6 (51727-6)
cellulose, croscarmellose sodium, D&C Yellow #10 Lake, lactose monohydrate, methacrylic acid co-polymer, PEG, polacrilin potassium, polyvinyl alcohol, silica, sodium lauryl sulfate, soya powder, talc, titanium dioxide, triethyl citrate
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8565-8
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
1-800-540-3765
Section 55105-1 (55105-1)
Pain reliever
Section 55106-9 (55106-9)
Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug
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Source: dailymed · Ingested: 2026-02-15T12:05:28.490520 · Updated: 2026-03-06T01:22:22.730099