ASPIRIN 81 MG- aspirin 81 mg tablet, chewable 
Cardinal Health 107, LLC

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.

----------

Drug Facts
Aspirin Chewable Tablets, 81 mg (NSAID*)

Active ingredient

Compare to Bayer® active ingredient

Active ingredient (in each tablet)

Aspirin 81 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of the reach of children.

Uses

Temporary relief of minor aches and pains or as recommended by your doctor – to reduce fever

Generic Section

Directions

Drink a full glass of water with each dose

-adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

-children under 25 years; consult a doctor

Warnings

This Unit Dose package is not child resistant and is intended for institutional use only. Keep out of reach of children. In case of accidental overdose, get medical help or, contact a Poison Control Center immediately.

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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 non prescription 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 – this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.

Directions

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 -anticoagulation (thinning the blood) – diabetes - gout - 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: feeling faint, vomit blood, have bloody or black stools, have stomach pain that does not get better - pain gets worse or lasts for more than 10 days -new symptoms occur - redness or swelling is present - ringing in the ears or loss of hearing occurs – you may report side effects to 1-888-952-0050

Inactive ingredients

dextrates, FD&C Yellow #6, flavor, saccharin sodium, starch

Storage

Store at Controlled Room Temperature 15- 30C (59-86F) and in a dry place.

SKY

MFG. BY: Allegiant Health. 75 North Industry Ct., Deer Park, NY 11729

Dist. BY: McKesson Packaging Services a business unit of McKesson Corporation

7101 Weddington Rd.

Concord, NC 28027

Health A2Z® Children's Aspirin is not manufactured or distributed by Bayer Consumer Care, distributor of Bayer®

Distributed By:

Cardinal Health

Dublin, OH 43017

L4099107-10718

L4099107-20718

Principal Display Panel

Aspirin Chewable Tablets, 81 mg (NSAID*)

81 mg

10 Tablets

bag label
ASPIRIN 81 MG 
aspirin 81 mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1473(NDC:63739-434)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize7mm
FlavorORANGEImprint Code AZ013
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-1473-010 in 1 BAG12/18/201404/30/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/18/201404/30/2021
Labeler - Cardinal Health 107, LLC (118546603)

Revised: 12/2022
 
Cardinal Health 107, LLC