BAYER ASPIRIN EXTRA STRENGTH CAPLETS- bayer aspirin extra strength tablet 
Bayer HealthCare LLC.

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BAYER Aspirin Extra Strength Caplets

Drug Facts

Active ingredient (in each caplet)

Aspirin 500 mg (NSAID) 1


1
nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

Uses

temporarily relieves

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

● feel faint ● vomit blood ● have bloody or black stools

● have stomach pain that does not get better

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

Other Information

Inactive ingredients

carnauba wax, corn starch, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments?1-800-331-4536 (Mon – Fri 9AM – 5PM EST)

Carton 100 caplets

Carton

BAYER ASPIRIN  EXTRA STRENGTH CAPLETS
bayer aspirin extra strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code Extra;Strength;BAYER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-2020-101 in 1 CARTON12/23/2014
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01312/23/2014
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIBusiness Operations
Bayer HealthCare LLC Consumer Care072827066manufacture(0280-2020) , pack(0280-2020)

Revised: 11/2023
Document Id: 0b618633-736e-6799-e063-6294a90a04f1
Set id: 0ae64cdb-4ea0-23af-e054-00144ff88e88
Version: 5
Effective Time: 20231130
 
Bayer HealthCare LLC.