ASPIRIN- aspirin tablet, chewable 
Cardinal Health

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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Aspirin Orange Flavored Chewable Tablets, 81 mg

Active ingredient

Aspirin, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drugs

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor
ask your doctor about other uses for this product

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
shock
facial swelling
asthma (wheezing)

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
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have had stomach ulcers or bleeding problems
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

Ask a doctor before use if

the 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

you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms occur
ringing in the ears or a loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present

These could be signs of a serious illness.

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 (1-800-222-1222).

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 12 years: consult a doctor

Other information

store at room temperature
avoid excess heat and moisture
save carton for full directions and warnings

Inactive ingredients

dextrose anhydrous, FD&C yellow #6 aluminum lake, microcrystalline cellulose, mint flavor, orange flavor, pregelatinized starch, saccharin sodium, talc

Questions or comments?

1-888-341-9214

Package/Label Principal Display Panel

NDC 70000-0103-1

Pain Reliever

Adult Aspirin, 81 mg

Low Dose NSAID

Orange Flavored

36 Tablets

Aspirin Carton
ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0103
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)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGE, MINTImprint Code 021
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0103-11 in 1 CARTON08/15/201601/31/2020
136 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70000-0103-21000 in 1 BOTTLE; Type 0: Not a Combination Product08/15/201601/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/15/201601/31/2020
Labeler - Cardinal Health (097537435)

Revised: 2/2020
 
Cardinal Health