Gc 983

Gc 983
SPL v2
SPL
SPL Set ID 0548591b-6cd2-4977-a346-fdf5bd04eead
Route
ORAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Polacrilin Potassium Polyvinyl Alcohol, Unspecified Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Microcrystalline Cellulose Lactose Monohydrate Polyethylene Glycol, Unspecified Soybean Silicon Dioxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: p Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-12

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


Advanced Ingredient Data


Raw Label Data

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