482r_albertson_21130-428_aspirin Delayed -release Tablets Usp, 81mg Ec

482r_albertson_21130-428_aspirin Delayed -release Tablets Usp, 81mg Ec
SPL v3
SPL
SPL Set ID f300dfbc-7137-79d1-e053-2995a90a636e
Route
ORAL
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Anhydrous Lactose Carnauba Wax Fd&c Red No. 40 Aluminum Lake Sodium Hydroxide Silicon Dioxide Croscarmellose Sodium Polysorbate 80 Talc Fd&c Yellow No. 6 Aluminum Lake Ferric Oxide Yellow Dimethicone Sodium Lauryl Sulfate Microcrystalline Cellulose Methacrylic Acid And Ethyl Acrylate Copolymer Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Shape: round Color: pink Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-08

Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug


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 • 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 problem
  • 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

Uses

• temporarily relieves minor aches and pain

• ask your doctor about other uses for enteric coated 81 mg Aspirin.

Dosage and Administration

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years of age 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 of age: do not use unless directed by a doctor
Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Section 42228-7

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 50565-1

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

Section 50566-9

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 stools ● have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • ringing in the ears or a loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or arthritis

Section 50569-3

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
Section 50570-1

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 51727-6

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, triethyl citrate

Section 51945-4

Section 53413-1

Questions or comments? 1-877-290-4008

Section 55105-1

Purpose

Pain reliever

Section 55106-9

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

  • store at 20-25°C (68-77°F)
  • close cap tightly after use

Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves minor aches and pain

• ask your doctor about other uses for enteric coated 81 mg Aspirin.

Dosage and Administration (34068-7)

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years of age 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 of age: do not use unless directed by 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 • 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 problem
  • 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 42228-7 (42228-7)

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 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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 stools ● have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • ringing in the ears or a loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or arthritis

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 51727-6 (51727-6)

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, triethyl citrate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-877-290-4008

Section 55105-1 (55105-1)

Purpose

Pain reliever

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

  • store at 20-25°C (68-77°F)
  • close cap tightly after use

Advanced Ingredient Data


Raw Label Data

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