FDA Label for Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves:
- minor pain of arthritis
- headache
- muscle pain
- menstrual pain
- toothache
- pain and fever of colds
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:
- asthma (wheezing)
- hives
- facial swelling
- shock
- 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]
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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
Ask A Doctor Before Use If
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for
- gout
- diabetes
- arthritis
Stop Use And Ask A Doctor If
- 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
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
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 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 (1-800-222-1222) right away.
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycol
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 63868-352-03
QC®
QUALITY
CHOICE
†Compare to the
active ingredient in
Genuine BAYER® Aspirin
Aspirin
(NSAID)
Pain Reliever
Fever Reducer 325mg
Coated Tablets
Easy to Swallow
300 Tablets
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
50844 REV0915A15717
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