FDA Label for Aspirin Enteric Coated, Regular Strength
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
- PRINCIPAL DISPLAY PANEL
Aspirin Enteric Coated, Regular Strength Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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
Uses
- for the temporary relief of minor aches and pains due to:
- colds
- headache
- toothache
- muscle pain
- menstrual pain
- minor pain of arthritis
- or as recommended by a doctor
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)
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
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.
Ask A Doctor Before Use If
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
you have asthma
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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- redness or swelling is present
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
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 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 to 2 tablets every 4 hours while symptoms last
do not take more than 12 tablets in 24 hours unless directed by a doctor.
children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ
NDC 0363-0227-57
ENTERIC COATED
REGULAR STRENGTH
Aspirin 325
325 mg / Pain Reliever (NSAID)
• Safety coated for aspirin regimen users
• Easy to swallow
125 ENTERIC
COATED TABLETS
Compare to Ecotrin® active ingredientǂǂ
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
ǂWalgreens Pharmacist Survey Study, November 2012.
ǂǂThis product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin®.
50844 REV1113A22757
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
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