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Enteric Coated Aspirin by State of Florida DOH Central Pharmacy

Medically reviewed on October 2, 2017

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: State of Florida DOH Central Pharmacy
NDC Code: 53808-1034

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.

Enteric Coated Aspirin Regular Strength

ACTIVE INGREDIENTS (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 Not Use

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
  • store at room temperature
  • do not use if imprinted safety seal under cap is broken or missing

You may report serious side effects to: 1-888-952-0050

INACTIVE INGREDIENTS

corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

SUPPLIER STATEMENT

This Product was Manufactured By:

Qualitest Pharmaceuticals, Inc
Huntsville, AL
USA

And Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA

PACKAGE LABEL

Label Image for 53808-1034
325mg

ENTERIC COATED ASPIRIN  
regular strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-1034(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:53808-1034-130 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34301/01/2014
Labeler - State of Florida DOH Central Pharmacy (829348114)
Establishment
NameAddressID/FEIOperations
State of Florida DOH Central Pharmacy829348114repack(53808-1034)

 
State of Florida DOH Central Pharmacy

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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