Aspirin by KEM Pharma LLC / LNK International, Inc. ASPIRIN tablet, coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by KEM Pharma LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains due to:
  • colds
  • toothache
  • menstrual pain
  • headache
  • muscle pain
  • minor pain of arthritis
• or as recommended by a doctor

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:

• shock
• facial swelling
• 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
• take more or for a longer time than directed
• 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

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 asthma
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic 

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• 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
• an allergic reaction occurs. Seek medical help right away.
• new symptoms occur
• ringing in the ears or loss of hearing occurs
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present

These could be signs of a serious condition. 

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 (1-800-222-1222) 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: ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

Enteric
Aspirin 325 mg
Pain Reliever (NSAID)

Enteric Coated Orange Tablets

Actual Size

Safety Coated
Aspirin Regimen
Regular Strength 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CLOSE TIGHTLY
TO OPEN PUSH DOWN AND TURN

This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin®.

50844     ORG111322712

Kem Pharma 44-227

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60503-227
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;227
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60503-227-12	1 in 1 CARTON	12/14/1992
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		12/14/1992

Labeler - KEM Pharma LLC (079090402)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(60503-227)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(60503-227)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(60503-227) , PACK(60503-227)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(60503-227)