ASPIRIN- aspirin tablet, coated 
Advanced Rx Pharmacy of Tennessee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aspirin 325g Tablet

Active Ingredient (in each tablet)

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

Pain reliever

temporarily relieves minor aches and pains due to:
headache
muscle pain
toothache
menstrual pain
colds
minor pains of arthritis
temporarily reduces fever

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:

Stomach bleeding warning:

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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.

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

Directions

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Other Information

store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)

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

Manufacturer: 1-800-540-3765

Other information

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Stop use and ask a doctor if

label 1label 2label 3

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0293(NDC:57896-921)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80425-0293-130 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2023
2NDC:80425-0293-260 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2023
3NDC:80425-0293-390 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/27/2023
Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0293)

Revised: 4/2023
Document Id: f8375029-e568-c6a5-e053-6394a90a5b67
Set id: f8375029-e567-c6a5-e053-6394a90a5b67
Version: 1
Effective Time: 20230427
 
Advanced Rx Pharmacy of Tennessee, LLC