ASPIRIN LOW DOSE CHEWABLE ORANGE- aspirin tablet, chewable 
Cardinal Health 107, LLC

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Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommneded by your doctor
ask your doctor about other uses for Chewable Aspirin 81 mg

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
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 have asthma
you are taking a diuretic

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 get worse or lasts more than 3 days
redness or swelling is present
ringing in the ears or loss of hearing occurs
any new symptoms occur

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 accidental 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 4 to 8 tablets every 4 hours not exceed 48 tablets in 24 hours unless directed by a doctor

 children under 12 years

consult a doctor

Other information

store at room temperature (150-300C)
Tamper Evident: do not use if sealed blister units are broken or damaged

Distributed By:

Cardinal Health

Dublin, OH 43017

L5920616-10624

L5920616-20624

Inactive ingredients

corn starch, dextrose monohydrate, FD&C yellow #6, orange flavor, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

1-800-616-2471

Principal Display Panel

ASPIRIN LOW DOSE CHEWABLE

ORANGE PAIN RELIEVER (NSAID) TABLETS

81 mg

10 CHEWABLE TABLETS

81mg bag label
ASPIRIN LOW DOSE CHEWABLE ORANGE 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2635(NDC:0904-6794)
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)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize8mm
FlavorImprint Code PH034
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-2635-010 in 1 BAG06/25/2024
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 DrugM01306/25/2024
Labeler - Cardinal Health 107, LLC (118546603)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675REPACK(55154-2635)

Revised: 6/2024
Document Id: 21042405-9c7e-4a72-8984-27ad3433eaa9
Set id: 21042405-9c7e-4a72-8984-27ad3433eaa9
Version: 1
Effective Time: 20240625
 
Cardinal Health 107, LLC