ASPIRIN  - aspirin tablet, delayed release 
TIME CAP LABORATORIES INC.

Each tablet contains - Aspirin 325 mg (NSAID)

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

PAIN RELIEVER

For the temporary relief of minor aches and pains due to: muscle pain, toothache, headache, colds, menstrual pain, minor pain of arthritis or as directed by your physician

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.

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: facial swelling, shock, hives, 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.

acetylted monoglycerides, corn starch, croscarmellose sodium,D-C yellow #10, FD-C yellow #6, hypromellose,hypromellose phthalate,microcrystalline cellulose,mineral oil,polyethylene glycol (PEG) 400, polysorbate 80, titanium dioxide

ASPIRIN  aspirin  tablet, delayed release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 49483-052 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength DIACETYLATED MONOGLYCERIDES   STARCH, CORN   CROSCARMELLOSE SODIUM   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   HYPROMELLOSES   HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)   CELLULOSE, MICROCRYSTALLINE   MINERAL OIL   POLYETHYLENE GLYCOL 400   POLYSORBATE 80   TITANIUM DIOXIDE

Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code T Contains

Packaging # NDC Package Description Multilevel Packaging 1 49483-052-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 49483-052-10 1000 TABLET In 1 BOTTLE, PLASTIC None 3 49483-052-00 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	05/08/2022

Labeler - TIME CAP LABORATORIES INC. (037052099)

Establishment
Name	Address	ID/FEI	Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture

Revised: 05/2012TIME CAP LABORATORIES INC.