Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 8cacf02c-9925-40d4-92bc-78788aa0681a
Route
ORAL
Published
Effective Date 2020-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: A Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-11

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. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 3 or more alcoholic drinks every day while using this product ■ 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 have ever had an allergic reaction to any other pain reliever/fever reducer
Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information
  • store at room temperature 20°– 25°C (68°–77°F)
  • do not use if imprinted seal under safety cap is broken or missing



Inactive Ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum

lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, silicon

dioxide, stearic acid, talc, titanium dioxide, triethyl citrate

Questions and Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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 stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
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.

Keep Out of Reach of Children

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

Package/label Principal Display Panel
Aspirin
Ask A Doctor Or Pharmacist Before Use If You Are

are taking a prescription drug for  

  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses

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.

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 3 or more alcoholic drinks every day while using this product ■ 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 have ever had an allergic reaction to any other pain reliever/fever reducer
Active Ingredient (Active ingredient)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information
  • store at room temperature 20°– 25°C (68°–77°F)
  • do not use if imprinted seal under safety cap is broken or missing



Inactive Ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum

lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, silicon

dioxide, stearic acid, talc, titanium dioxide, triethyl citrate

Questions and Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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 stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
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 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.

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Aspirin
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

are taking a prescription drug for  

  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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