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Enteric Coated Aspirin by American Health Packaging

Medically reviewed on February 20, 2018

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: American Health Packaging
NDC Code: 68084-848

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.

ASPIRIN (NSAID) Regular Strength Enteric Coated Tablets

Anti-Inflammatory/Analgesic Pain Reliever

8284825/1115OS

Drug Facts

Active ingredient (in each tablet)
Aspirin 325mg (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
  • 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

Do n ot u se if you are allergic to aspirin or other pain relievers/fever reducers

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • 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
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days

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.

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 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other Information
  • Supplied as unit dose packages of 30 (5 x 6) NDC 68084-848-25
  • Store at room temperature
  • FOR YOUR PROTECTION: Do not use product if blister is torn or broken.

You may report serious side effects to A&Z Pharmaceutical, Inc.: 1-888-952-0050

Inactive Ingredients

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.

Questions?
  • about the packaging or to order more inserts call American Health Packaging at 1-800-707-4621

PACKAGING INFORMATION

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

Package/Label Display Panel – Carton – 325 mg

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

Package/Label Display Panel – Blister – 325 mg

ASPIRIN (NSAID)
Regular Strength
Enteric Coated Tablet
Anti-inflammatory/
Analgesic Pain Reliever

325 mg

ENTERIC COATED ASPIRIN 
regular strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-848(NDC:0603-0169)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
DIMETHICONE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
TITANIUM DIOXIDE 
TALC 
TRIETHYL CITRATE 
SODIUM HYDROXIDE 
FD&C YELLOW NO. 6 
POLYSORBATE 80 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
SODIUM LAURYL SULFATE 
MINERAL OIL 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeT
Contains    
Packaging
#Item CodePackage Description
1NDC:68084-848-2530 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:68084-848-951 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/09/201403/31/2019
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIOperations
American Health Packaging929561009repack(68084-848)

 
American Health Packaging

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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