SPL v2
SPL
SPL Set ID b499f378-db7c-464e-bee3-eb23f8fdaced
Route
ORAL
Published
Effective Date 2022-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Dextrates Fd&c Yellow No. 6 Saccharin Sodium Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-01

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

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
  • 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 three (3) or more alcoholic drinks every day while using this
  • take more or for a longer time than directed.
Directions
  • 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
Do Not Use
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients.
Other Information:
  • Store at room temperature.
Inactive Ingredients:

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium.

Principal Display Panel

Aspirin

81 mg

Chewable Tablet

Mfg: Allegiant Health

Lot:22A0131 Exp:09/06/24

PKG BY: Safecor Health

Woburn, MA

Ask A Doctor Before Use If
  • 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
Stop Use and Ask A Doctor If
  • an allergic reaction occurs. Seek medical help right away
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stool
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
Keep Out of Reach of Childen.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

It is especially important not to use aspirin during the last three (3) months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If

you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Purpose

Pain Reliever

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
  • 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 three (3) or more alcoholic drinks every day while using this
  • take more or for a longer time than directed.
Directions
  • 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
Do Not Use (Do not use)
  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients.
Other Information: (Other information:)
  • Store at room temperature.
Inactive Ingredients: (Inactive ingredients:)

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium.

Principal Display Panel

Aspirin

81 mg

Chewable Tablet

Mfg: Allegiant Health

Lot:22A0131 Exp:09/06/24

PKG BY: Safecor Health

Woburn, MA

Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • an allergic reaction occurs. Seek medical help right away
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stool
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
Keep Out of Reach of Childen. (Keep out of reach of childen.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

It is especially important not to use aspirin during the last three (3) months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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