LOW DOSE ASPIRIN- aspirin 81 mg delayed release tablets 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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481R WALGREENS 0363 0690 Aspirin 81 mg Tablet

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are
taking a prescription drug for:

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs of stomach bleeding:

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

ringing in the ears or a loss of hearing occurs

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

Other information

Store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

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

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LOW DOSE ASPIRIN 
aspirin 81 mg delayed release tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0690
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code Heart
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0690-121 in 1 CARTON10/08/2021
1120 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0363-0690-321 in 1 CARTON06/15/2022
232 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0363-0690-292 in 1 CARTON06/15/2022
3120 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0363-0690-201 in 1 CARTON06/15/2022
4200 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0363-0690-311 in 1 CARTON06/15/2022
5300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/08/2021
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099manufacture(0363-0690)

Revised: 5/2022
Document Id: df7fd50f-a3b4-6fe6-e053-2995a90ac4de
Set id: c25c3524-3e24-3410-e053-2995a90a73ed
Version: 4
Effective Time: 20220521
 
WALGREENS