ASPIRIN   - aspirin tablet, coated 
TIME CAP LABS INC

Each tablet contains Aspirin 325 mg

corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

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
You have lost a lot of fluid due to vomiting or diarrhea

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, asthma (wheezing)

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 any other pain reliever/fever reducer

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

Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Pain Reliever

Uses:

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.

ASPIRIN   aspirin  tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-011 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength STARCH, CORN   CROSCARMELLOSE SODIUM   HYPROMELLOSES   CELLULOSE, MICROCRYSTALLINE   MINERAL OIL   TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL011 Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-011-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 49483-011-00 100000 TABLET In 1 CARTON None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/18/2012

Labeler - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABS INC		037052099	manufacture

Revised: 04/2012TIME CAP LABS INC