ASPIRIN- aspirin tablet, film coated 
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.

----------

Aspirin Enteric Coated Tablets, 325 mg

Active ingredient

Aspirin, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves

headache
muscle pain
toothache
menstrual pain
pain and fever of colds
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
shock
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
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.

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
have bloody or black stools
vomit blood
have stomach pain that does not get better
any new symptoms occur
pain gets worse or lasts more than 10 days
redness or swelling is present
fever lasts more than 3 days
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 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 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
children under 12 years: consult a doctor

Other information

store at room temperature
save carton for full directions and warnings

Inactive ingredients

black iron oxide, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #5 aluminum lake, glyceryl monostearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, potassium hydroxide, povidone, pregelatinized starch, shellac, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, titanium dioxide

Questions or comments?

1-888-341-9214

Package/Label Principal Display Panel

NDC 70000-0107-1

Pain Reliever

Adult Aspirin, 325 mg

Regular Strength NSAID

125 Enteric Coated Tablets

Aspirin Carton

Principal Display Panel

NDC 70000-0107-1

Pain Reliever

Adult Aspirin, 325 mg

Regular Strength NSAID

125 Enteric Coated Tablets

C:\Users\mcraddock\Documents\SPL\Aspirin Enteric Coated 325 mg\Aspirin Enteric Coated 325mg Carton Old Style Guide.jpg
ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0107-11 in 1 CARTON08/15/201601/31/2020
1125 in 1 BOTTLE; Type 0: Not a Combination Product
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