LOW DOSE CHEWABLE ASPIRIN- aspirin tablet, chewable 
FSA STORE INC.

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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1105B-CRM-2023-0502

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:

  • 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 have ever had an allergic reaction to any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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 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
  • 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

These could be signs of a serious condition.

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 (1-800-222-1222).

Directions

Other information

Inactive ingredients

corn starch, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, silicon dioxide, sucrose

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

TRIPLE PACK | 3 Bottles of 36 Count Inside

NDC 81522-105-03

caring mill™

†Compare to the active ingredient of Bayer® Chewable Aspirin

Orange Flavored • Aspirin Regimen**

Low Dose Chewable Aspirin

Pain Reliever (NSAID) 

Talk to your doctor or other healthcare provider before using this product for your heart

Actual Size

108 TABLETS - 81 MG EACH

image description

LOW DOSE CHEWABLE ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code AP;009
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81522-105-033 in 1 CARTON05/02/2023
136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/02/2023
Labeler - FSA STORE INC. (049283340)

Revised: 5/2023
Document Id: faca6663-6a67-d0e0-e053-6394a90ac2c6
Set id: f939b44c-93b6-ca61-e053-6394a90ae586
Version: 2
Effective Time: 20230503
 
FSA STORE INC.