principal display panel

principal display panel
SPL v15
SPL
SPL Set ID 6c7db6a8-f017-4a15-a4a8-4fba82ff658d
Route
oral
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

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


Medication Information

Warnings and Precautions

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 shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take a blood thinning (anticoagulant) or steroid drug take more or for a longer time than directed 

Active Ingredient

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

Indications and Usage

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

Dosage and Administration

do not take more than directed drink a full glass of water with each dose chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Description

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

Section 44425-7

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number 

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away. 

Section 50566-9

an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood have bloody or black stools feel faint have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

Section 50568-5

taking a prescription drug for gout  diabetes arthritis

Section 50569-3

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 are taking a diuretic

Section 50570-1

if you are allergic to aspirin or any other pain reliever/fever reducer 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

corn starch, D & C red #27 aluminum lake, D & C red #30 aluminum lake, dextrates hydrated, flavor, maltodextrin, sucralose

Section 51945-4

QC ® QUALITY CHOICE NDC 63868-029-36 †Compare to the Active Ingredient in BAYER ® CHEWABLE LOW DOSE ASPIRIN Low Dose Chewable Aspirin Aspirin 81 mg Chewable Tablets Pain Reliever (NSAID) Chew or crush tablets completely before swallowing. Aspirin Regimen** Cherry Flavor 36 Tablets actual size **Talk to your doctor or other healthcare provider before using this product for your heart. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 100% QC SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. 43157 W Nine Mile Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 † This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer ® Chewable Low Dose Aspirin. 50844           REV0122B39707 Quality Choice 44-397A

Section 53413-1

1-800-426-9391

Section 53414-9

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

Section 55105-1

Pain reliever 


Structured Label Content

Warnings and Precautions (34071-1)

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 shock asthma (wheezing) 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] take a blood thinning (anticoagulant) or steroid drug take more or for a longer time than directed 

Active Ingredient (55106-9)

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

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

do not take more than directed drink a full glass of water with each dose chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor

Section 44425-7 (44425-7)

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number 

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away. 

Section 50566-9 (50566-9)

an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood have bloody or black stools feel faint have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

Section 50568-5 (50568-5)

taking a prescription drug for gout  diabetes arthritis

Section 50569-3 (50569-3)

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 are taking a diuretic

Section 50570-1 (50570-1)

if you are allergic to aspirin or any other pain reliever/fever reducer 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)

corn starch, D & C red #27 aluminum lake, D & C red #30 aluminum lake, dextrates hydrated, flavor, maltodextrin, sucralose

Section 51945-4 (51945-4)

QC ® QUALITY CHOICE NDC 63868-029-36 †Compare to the Active Ingredient in BAYER ® CHEWABLE LOW DOSE ASPIRIN Low Dose Chewable Aspirin Aspirin 81 mg Chewable Tablets Pain Reliever (NSAID) Chew or crush tablets completely before swallowing. Aspirin Regimen** Cherry Flavor 36 Tablets actual size **Talk to your doctor or other healthcare provider before using this product for your heart. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 100% QC SATISFACTION GUARANTEED ® Distributed by CDMA, Inc. 43157 W Nine Mile Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 † This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer ® Chewable Low Dose Aspirin. 50844           REV0122B39707 Quality Choice 44-397A

Section 53413-1 (53413-1)

1-800-426-9391

Section 53414-9 (53414-9)

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely 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)

Pain reliever 


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