xpect chewable aspirin

xpect chewable aspirin
SPL v1
SPL
SPL Set ID bddce374-1d35-4685-987d-4a4cc9994155
Route
oral
Published
Effective Date 2025-09-25
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 aluminum lake saccharin sodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-25

Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug 


Medication Information

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
Active Ingredient

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Indications and Usage

Uses 

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

Dosage and Administration

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
Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug 

Section 50565-1

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.

Section 50566-9

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 stool ■ 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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout 
  • diabetes 
  • arthritis
Section 50569-3

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
Section 50570-1

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer 
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

Call 1-877-973-2811 Monday – Friday 8 AM – 5 PM

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever

Section 60561-8

Other information

  • store at room temperature
  • do not use if packet is opened or torn
Principal Display Panel 25 Count Box

Compare to the active ingredient in Bayer® Chewable Aspirin†

CHEWABLE ASPIRIN

Active Ingredient:

Aspirin 

Pain Reliever (NSAID)

Low Dose (81 mg)

Xpect® First aid

25 Tablets / 25 Packets (1 tablet in each packet) per Box

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Aspirin. 


Structured Label Content

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
Active Ingredient (55106-9)

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Indications and Usage (34067-9)

Uses 

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

Dosage and Administration (34068-7)

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
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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 stool ■ 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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout 
  • diabetes 
  • arthritis
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer 
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 
  • if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-973-2811 Monday – Friday 8 AM – 5 PM

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • do not use if packet is opened or torn
Principal Display Panel 25 Count Box (Principal Display Panel - 25 Count Box)

Compare to the active ingredient in Bayer® Chewable Aspirin†

CHEWABLE ASPIRIN

Active Ingredient:

Aspirin 

Pain Reliever (NSAID)

Low Dose (81 mg)

Xpect® First aid

25 Tablets / 25 Packets (1 tablet in each packet) per Box

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Aspirin. 


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