BAYER PLUS EXTRA STRENGTH- aspirin tablet, coated 
Bayer HealthCare LLC.

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Bayer Plus-Extra Strength

Drug Facts

Active ingredient (in each caplet)

Buffered Aspirin 500 mg (NSAID) 1


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

for the temporary relief of

  • headache
  • pain and fever of colds
  • muscle pain
  • menstrual pain
  • toothache
  • minor pain of arthritis

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:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

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

  • gout
  • diabetes
  • arthritis

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:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever lasts more than 3 days
  • 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 right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 caplets every 4 to 6 hours as needed, not to exceed 8 caplets in 24 hours
  • children under 12 years: consult a doctor

Other information

  • each caplet contains: calcium 140 mg
  • save carton for full directions and warnings
  • store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients

calcium carbonate, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide, zinc stearate

Questions or comments? 1-800-331-45 36 (Mon – Fri 9AM – 5 PM EST)

bayerplus

BAYER PLUS  EXTRA STRENGTH
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-2040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code EXTRA;STRENGTH;BAYER;PLUS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-2040-501 in 1 CARTON01/12/2015
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/12/201502/28/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2023
 
Bayer HealthCare LLC.