ASPIRIN by TIME CAP LABS INC ASPIRIN tablet, coated

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by TIME CAP LABS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Each tablet contains Aspirin 325 mg (NSAID)

INACTIVE INGREDIENTS

Corn Starch, Croscramellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

PURPOSE

Pain Reliever

DOSAGE AND ADMINISTRATION

Drink a full glass of water with each doses

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.

INDICATIONS AND USAGE

For the temporary relief of aches and pains due to:

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

WARNINGS

Reyes'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 reactin, which may include hives, facial swelling, shock, asthma (wheezing)

Stomach bleeding warning:  This produc tcontains 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 non prescription 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 THE REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-011-10	1000 in 1 BOTTLE, PLASTIC
2	NDC: 49483-011-01	100 in 1 BOTTLE, PLASTIC
3	NDC: 49483-011-00	100000 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/02/2014

Labeler - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(49483-011)