e5e8a8d5-9174-7975-e053-2a95a90a9aa6
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
- shock
- asthma (wheezing)
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 problem
- take a blood thinning (anticoagulant) or steroid drug
- take other drug 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
for the temporary relief of minor aches and pains or as recommended by your
doctor.
Because of its delayed action, this product will not provide fast
relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for Safety Coated 81 mg Aspirin
Dosage and Administration
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to
exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
Description
Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Section 44425-7
- Store at room temprature. Avoid excessive heat above 40°C (104°F).
Section 50565-1
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9
an allergic reaction occurs. Seek medical help right away.
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
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
Section 50568-5
- gout
- diabetes
- arthritis
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
Section 50570-1
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6
microcrystalline cellulose, colloidal silicon dioxide,
croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
acid copolymer, talcum, titanium dioxide, triethyl citrate.
Section 51945-4
Section 53413-1
Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST
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.
KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a
Poison Control Center right away.
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 or as recommended by your
doctor.
Because of its delayed action, this product will not provide fast
relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for Safety Coated 81 mg Aspirin
Dosage and Administration (34068-7)
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to
exceed 48 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult 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
- shock
- asthma (wheezing)
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 problem
- take a blood thinning (anticoagulant) or steroid drug
- take other drug 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 room temprature. Avoid excessive heat above 40°C (104°F).
Section 50565-1 (50565-1)
In case of overdose, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
an allergic reaction occurs. Seek medical help right away.
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
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
Section 50568-5 (50568-5)
- gout
- diabetes
- arthritis
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
Section 50570-1 (50570-1)
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)
microcrystalline cellulose, colloidal silicon dioxide,
croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
acid copolymer, talcum, titanium dioxide, triethyl citrate.
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST
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.
KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a
Poison Control Center right away.
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: 2026-02-15T12:02:40.651053 · Updated: 2026-03-14T23:02:21.986500