SPL v2
SPL
SPL Set ID e5e8a8d5-9174-7975-e053-2a95a90a9aa6
Route
ORAL
Published
Effective Date 2022-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Stearic Acid Triethyl Citrate Methacrylic Acid - Ethyl Acrylate Copolymer (1:2) Talc Silicon Dioxide Microcrystalline Cellulose Croscarmellose Sodium Titanium Dioxide D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: I1 Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-10

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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