ENTERIC COATED ASPIRIN  REGULAR STRENGTH - aspirin tablet, delayed release 
Time-Cap Labs, Inc

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Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer
  

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 are taking a diuretic
• you have asthma
• you have not been drinking fluids
  

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor's care for any serious condition
  

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding
• • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• ringing in the ears or a loss of hearing occurs
  

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, 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 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor
  

Other information

• store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
• use by expiration date on package
  

corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

Pain Reliever

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, shock, asthmaaa9wheezing)

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.

In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

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ENTERIC COATED ASPIRIN   REGULAR STRENGTH aspirin   tablet, delayed release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-331 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (ASPIRIN) ASPIRIN 325 mg  in 325

Inactive Ingredients Ingredient Name Strength MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)   croscarmellose sodium   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A   CELLULOSE, MICROCRYSTALLINE   polysorbate 80   DIMETHICONE   SILICON DIOXIDE   SODIUM HYDROXIDE   SODIUM LAURYL SULFATE   TALC   TITANIUM DIOXIDE   TRIETHYL CITRATE

Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code T Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-331-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 49483-331-00 100000 TABLET In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	11/23/2010

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Operations
Time-Cap Labs, Inc		037052099	manufacture

Revised: 11/2010Time-Cap Labs, Inc