FDA Label for Chewable Adult Low Dose Aspirin
View Indications, Usage & Precautions
Chewable Adult Low Dose Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals 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 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:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do Not Use
Ask A Doctor Before Use If
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
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, In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Other Information
Inactive Ingredients
corn starch, dextrose, FD&C yellow #6 aluminum lake, flavors, maltodextrin, sucralose.
Principal Display Panel
DRxChoice
compare to Bayer® Chewable Low Dose Aspirin active ingredients**
NDC 68163-081-91
low dose
CHEWABLE ASPIRIN
81 mg tablets
pain reliever (NSAID)
orange flavor
aspirin regimen
36 Chewable Tablets
3 bottles - 36 tablets each
value pack
DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.
GLUTEN-FREE (less than 20ppm gluten. If you have specific dietary needs you should consult a doctor before consuming this product.
Distributed By:
Raritan Pharmaceuticals Inc
8 Joanna Court
* Please review the disclaimer below.