372 - Aspirin 81mg

372 - Aspirin 81mg
SPL v4
SPL
SPL Set ID 04017bc9-602a-4204-96a9-b7f9713155f6
Route
ORAL
Published
Effective Date 2023-01-31
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 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid 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 2023-01-31

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

Use(s)

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.

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 non prescription 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 are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
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
Active Ingredient(s)

Aspirin 81mg (NSAID)* 

*nonsteroidal anti-inflammatory drug



Inactive Ingredients

ccolloidal 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 citrate.

Pregnancy/breastfeeding

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.



Principal Display Panel
Aspirin 81mg EC
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
  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children

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

Ask A Doctor Or Pharmacist Before Use If
  • taking a prescription drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Use(s)

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.

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 non prescription 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 are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information (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
Active Ingredient(s) (Active ingredient(s))

Aspirin 81mg (NSAID)* 

*nonsteroidal anti-inflammatory drug



Inactive Ingredients (Inactive ingredients)

ccolloidal 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 citrate.

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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.



Principal Display Panel
Aspirin 81mg EC
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
  • You may report side effects to 1-888-952-0050
Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • taking a prescription drug for anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)