ASPIRIN 325 MG- aspirin tablet 
WALGREENS

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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331R Walgreens 0363-6453 Aspirin 325 mg 500s

DRUG FACTS

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:
o headache
o toothache
o muscle pain
o minor arthritis pain
o menstrual pain
o colds
• 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:

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 have ever had an allergic reaction to 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if:
you experience any of the following signs of stomach bleeding:

Seek medical help right away 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information
each tablet contains: sodium 1 mg (VERY LOW SODIUM)
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
• use by expiration date on package

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments? Call 1-877-290-4008

331R-WG-Aspirin325-label-500s

ASPIRIN 325 MG 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6453
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6453-53500 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/15/2022
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(0363-6453)

Revised: 5/2022
Document Id: dfa65626-0d4d-b7df-e053-2a95a90ac1d5
Set id: d71a22e8-9e39-a672-e053-2a95a90a1403
Version: 2
Effective Time: 20220522
 
WALGREENS