Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 58a371d4-1f00-4fda-8e08-80610c58505a
Route
ORAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide D&c Yellow No. 10 Aluminum Lake Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Cellulose, Microcrystalline Titanium Dioxide Triethyl Citrate Talc Starch, Corn Crospovidone Fd&c Yellow No. 6 Hypromelloses Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: A Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-01

Description

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

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

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

Uses

For the temporary relief of minor aches and pain 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.

Section 51945-4

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 included

  • hives 
  • facial swelling
  • asthma (wheezing) 
  • shock

Stomach Bleeding Warning: this product containers 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 you are allergic to aspirin or any other pain reliever / fever reducer

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 have asthma
  • You have taken a diuretic

Ask a doctor or pharmacist before use ifyou are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

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
  • Redness or swelling is present
  • Ringing in the ears or loss of hearing occurs
  • Pain gets worse or lasts more than 10 days

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 of age:consult a doctor

Active Ingredient

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, corn starch, crospovidone, D C yellow 10 aluminum lake, FD C yellow 6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl ceitrate

Keep Out of Reach of Children

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.


Structured Label Content

Uses

For the temporary relief of minor aches and pain 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.

Section 51945-4 (51945-4)

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 included

  • hives 
  • facial swelling
  • asthma (wheezing) 
  • shock

Stomach Bleeding Warning: this product containers 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 you are allergic to aspirin or any other pain reliever / fever reducer

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 have asthma
  • You have taken a diuretic

Ask a doctor or pharmacist before use ifyou are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

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
  • Redness or swelling is present
  • Ringing in the ears or loss of hearing occurs
  • Pain gets worse or lasts more than 10 days

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 of age:consult a doctor

Active Ingredient

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, corn starch, crospovidone, D C yellow 10 aluminum lake, FD C yellow 6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl ceitrate

Keep Out of Reach of Children (Keep out of Reach of Children)

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.


Advanced Ingredient Data


Raw Label Data

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