ENTERIC COATED ASPIRIN- regular strength tablet
American Health Packaging
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.
----------
Active ingredient (in each tablet)
Aspirin 325mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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.
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 n ot u se if you are allergic to aspirin or other pain relievers/fever reducers
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
Stop use and ask a doctor if
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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.
You may report serious side effects to A&Z Pharmaceutical, Inc.: 1-888-952-0050
corn starch, croscarmellose sodium, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
American Health Packaging unit dose blisters contain drug product from Qualitest Pharmaceuticals as follows:
(325 mg / 30 UD) NDC 68084-848-25 packaged from NDC 0603-0169.
Distributed by: American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217
8284825/1115OS
NDC 68084-848-25
ASPIRIN (NSAID)
Regular Strength Enteric Coated Tablets
Anti-inflammatory/Analgesic Pain Reliever
325 mg
30 Tablets (5 × 6)
Drug Facts
Active Ingredient (in each tablet) Purpose
Aspirin 325 mg (NSAID*) .............................................. Pain reliever
*nonsteroidal anti-inflammatory drug
Uses
See package insert for complete Drug Facts information
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 • asthma
(wheezing) • shock
Stomach bleeding warning: This product contains an NSAID,
which may cause severe stomach bleeding. The chance is
higher if you: • 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
Keep Out of Reach of Children. In case of overdose, get
medical help or contact a Poison Control Center right away.
See Package Insert for additional Drug Facts Warnings.
Directions
See package insert for complete Drug Facts information.
Other Information
• store at room temperature •
FOR YOUR PROTECTION: Do
not use if blister is torn or broken •
You may report serious
side effects to A&Z Pharmaceutical, Inc.: 1-888-952-0050
The drug product contained in this package is from
NDC # 0603-0169, Qualitest Pharmaceuticals.
Distributed by: American Health Packaging,
2550 John Glenn Avenue, Suite A,
Columbus, OH 43217
084825
0284825/1115OS
ENTERIC COATED ASPIRIN
regular strength tablet |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
Labeler - American Health Packaging (929561009) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
American Health Packaging | 929561009 | repack(68084-848) |