FDA Label for Low Dose Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CHEWABLE 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
Low Dose 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 Chewable Tablet)
Aspirin 81 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
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 a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
- have had stomach ulcers or bleeding problems
- 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
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
- if you have ever had an allergic reaction to this product or any of its ingredients
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
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:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- vomit blood
- ringing in the ears or a loss of hearing occurs
- pain gets worse or lasts more than 10 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 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
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable 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); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
QC
QUALITY®
CHOICE
NDC 63868-332-36
†Compare to the Active Ingredient in Bayer® Chewable Low Dose Aspirin
Low Dose
Aspirin
81 mg Chewable Tablets
Pain Reliever (NSAID)
Chew or crush tablets completely before swallowing.
36 Chewable 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 AG, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
50844 ORG111821807
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