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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 

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 

Section 55106-9

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


Structured Label Content

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

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 

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 

Section 55106-9 (55106-9)

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


Raw Label Data

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