ASPIRIN- aspirin tablet, chewable
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
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:
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
take more or for a longer time than directed
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
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
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
taking a prescription drug for
you experience any of the following signs of stomach bleeding:
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present
These could be signs of a serious condition.
drink a full glass of water with each dose
store at 25°C (77ºF); excursions permitted between 15º-30°C (59°-86°F)
see end flap for expiration date and lot number
corn starch, dextrates, FD&C yellow #6 aluminum lake, orange enhancer, orange flavor, sodium saccharin
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
HEALTHCARE™
NDC 64092-150-36
†Compare to the active ingredient in St. Joseph® 81 mg Chewable Aspirin
81 mg LOW STRENGTH
Low Dose Aspirin
Pain Reliever (NSAID)
For Aspirin Regimen Users
For Minor Aches and Pains
36 CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by St. Josephs Health Products, LLC, owner of the registered trademark St. Joseph® 81 mg Chewable Aspirin.
50844 REV0613C21807
Distributed by: Great Lakes Wholesale & Marketing, L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
Healthcare 44-218
ASPIRIN
low dose aspirin tablet, chewable |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 038154464 | PACK(64092-000) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
LNK International, Inc. | 832867894 | MANUFACTURE(64092-000) |