288 -aspirin Low Dose Chewable Tablet

288 -aspirin Low Dose Chewable Tablet
SPL v3
SPL
SPL Set ID 4a76e898-3204-4f77-bc67-c19f5fe829f3
Route
ORAL
Published
Effective Date 2023-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Dextrates Fd&c Yellow No. 6 Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Imprint: AZ013 Shape: round Color: orange Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-08

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 pains or as recommended by your doctor

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 are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Other Information

save carton for full directions and warnings

store at room temperature.



Questions/comments

Call 1-888-952-0050 (Mon-Fri 9AM-5PM EST)

Active Ingredient(s)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium



Principal Display Panel
Aspirin
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 than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breastfeeding,

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 Poison Control Center(1-800-222-1222) immediately.

Ask A Doctor Or Pharmacist Before Use If

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Use(s)

for the temporary relief of minor aches and pains or as recommended by your doctor

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 are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Other Information (Other information)

save carton for full directions and warnings

store at room temperature.



Questions/comments (Questions/Comments)

Call 1-888-952-0050 (Mon-Fri 9AM-5PM EST)

Active Ingredient(s) (Active ingredient(s))

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium



Principal Display Panel
Aspirin
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 than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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 (Keep out of reach of children)

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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