FDA Label for Aspirin
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Aaa Pharmaceutical, 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.
Other
Drug Facts
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
Active Ingredient (In Each Tablet)
Aspirin 325 mg (NSAID
nonsteroidal anti-inflammatory drug
)Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves:
- headache
- muscle pain
- toothache
- menstrual pain
- pain of colds
- minor pain of arthritis
- temporarily reduces fever
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
- 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
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- diabetes
- gout
- arthritis
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 stools
- have stomach pain that does not get better
- pain gets worse or lasts for more than 10 days
- redness or swelling is present
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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.
Otc - 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 (1-800-222-1222).
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: consult a doctor
Other Information
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information
Inactive Ingredients
croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, starch, titanium dioxide
Principal Display Panel - 100 Tablet Bottle Carton
RESTORE u
NDC 57344-018-11
†COMPARE TO THE
ACTIVE INGREDIENT IN
BAYER® ASPIRIN
REGULAR
STRENGTH
Coated for
Easy Swallowing
Aspirin
Pain Reliever / Fever Reducer
(NSAID)
100 COATED TABLETS - 325 mg each
* Please review the disclaimer below.