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 Topco Associates, Llc. 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 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.
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)
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
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
- 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
- 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
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- pain gets worse or lasts more than 10 days
- redness or swelling is present
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 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 not to exceed 12 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 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
black iron oxide, cellulose, colloidal anhydrous silica, 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
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare®
health
NDC 36800-127-57
COMPARE TO ECOTRIN® REGULAR STRENGTH
ACTIVE INGREDIENT†
REGULAR STRENGTH ASPIRIN REGIMEN††
Aspirin 325 mg
Pain reliever (NSAID)
Safety Coated
††Talk to your doctor or other healthcare provider before using this product for your heart.
125 ENTERIC COATED TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATS LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0221
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
QUALITY GUARANTEED
†This product is not manufactured or
distributed by Medtech Products Inc.,
owner of the registered trademark
Ecotrin® Regular Strength.
50844 ORG031822757
* Please review the disclaimer below.