ASPIRIN- aspirin tablet, delayed release 
INVAHEALTH INC

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Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Pain reliever

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:

Stomach bleeding warning:This product contains an NSAID, which may cause
severe stomach bleeding. The chance is higher if you:

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:

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.

exceed 48 tablets in 24 hours unless directed by a doctor

Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST

microcrystalline cellulose, colloidal silicon dioxide,
croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
acid copolymer, talcum, titanium dioxide, triethyl citrate.

for the temporary relief of minor aches and pains or as recommended by your
doctor. Because of its delayed action, this product will not provide fast
relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for Safety Coated 81 mg Aspirin

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

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ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73376-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73376-001-50500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/10/2022
Labeler - INVAHEALTH INC (116840615)

Revised: 1/2024
Document Id: 0e7604d4-4181-6453-e063-6394a90a515e
Set id: e5e8a8d5-9174-7975-e053-2a95a90a9aa6
Version: 2
Effective Time: 20240108
 
INVAHEALTH INC