quality choice 44-600a-ndc 63868-363

quality choice 44-600a-ndc 63868-363
SPL v19
SPL
SPL Set ID f1ce15a3-9824-4eb5-910a-39078165f385
Route
oral
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (81 mg)
Inactive Ingredients
starch, corn d&c yellow no. 10 fd&c yellow no. 6 hypromellose, unspecified methacrylic acid microcrystalline cellulose polydextrose polyethylene glycol, unspecified shellac silicon dioxide dimethicone water sodium bicarbonate sodium lauryl sulfate talc titanium dioxide triacetin triethyl citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
otc monograph drug active Since 2011-05-01 Until 2027-12-31

Purpose

Pain reliever

Description

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product

Active Ingredient

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains 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

Directions
  • do not take more than directed
  • 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: do not use unless directed by a doctor
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Description

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

Principal Display Panel

NDC 63868-363-20

QC®

QUALITY

CHOICE

Compare to the

Active Ingredient in

BAYER® Low Dose Aspirin

Enteric Coated

Aspirin 81 mg

Low Dose

Pain Reliever (NSAID)

Aspirin Regimen**

120 Tablets (81 mg Each)

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

This product is not manufactured or distributed by

Bayer AG, owner of the registered trademark

BAYER® Low Dose Aspirin.

50844       REV0122D60032

SATISFACTION

GUARANTEED

100%


QC

Distributed by CDMA, Inc.

43157 W. Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions:800-935-2362



Quality Choice 44-600A


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
Questions Or Comments?

1-800-426-9391

Ask A Doctor Before Use If
  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease



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:
    • 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.

If Pregnant Or Breast Feeding,

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.

Keep Out of Reach of Children.

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

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
  • shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product

Active Ingredient (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains 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

Directions
  • do not take more than directed
  • 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: do not use unless directed by a doctor
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

NDC 63868-363-20

QC®

QUALITY

CHOICE

Compare to the

Active Ingredient in

BAYER® Low Dose Aspirin

Enteric Coated

Aspirin 81 mg

Low Dose

Pain Reliever (NSAID)

Aspirin Regimen**

120 Tablets (81 mg Each)

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

This product is not manufactured or distributed by

Bayer AG, owner of the registered trademark

BAYER® Low Dose Aspirin.

50844       REV0122D60032

SATISFACTION

GUARANTEED

100%


QC

Distributed by CDMA, Inc.

43157 W. Nine Mile

Novi, MI 48375

www.qualitychoice.com

Questions:800-935-2362



Quality Choice 44-600A


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
Questions Or Comments? (Questions or comments?)

1-800-426-9391

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease



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:
    • 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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