ENTERIC COATED ASPIRIN REGULAR STRENGTH- aspirin tablet, delayed release 
McKesson Corporation dba SKY Packaging

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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331R ASA DR ORANGE TABS 325 MG

Do not use


Ask a doctor before use if


Ask a doctor or pharmacist before use if you are


Stop use and ask a doctor if


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.

Directions


Other information


corn starch, croscarmellose sodium,D-C yellow #10 aluminum lake, FD-C yellow#6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil,  polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

Pain Reliever

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, asthmaaa9wheezing)

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.

In each Tablet Asprin 325 mg (NSAID*) *non-steroidal anti-inflammatory drug

HOW SUPPLIED

Product: 63739-523

NDC: 63739-523-01 30 TABLET, DELAYED RELEASE in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

Enteric Coated AspirinRegular Strength Regular Strength

Label Image
ENTERIC COATED ASPIRIN  REGULAR STRENGTH
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-523(NDC:49483-331)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg  in 325 
Inactive Ingredients
Ingredient NameStrength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63739-523-0125 in 1 BOX, UNIT-DOSE06/28/201312/31/2020
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/04/2011
Labeler - McKesson Corporation dba SKY Packaging (140529962)
Establishment
NameAddressID/FEIBusiness Operations
Legacy Pharmaceutical Packaging, LLC143213275repack(63739-523) , relabel(63739-523)

Revised: 1/2021
Document Id: b95a7f47-ccae-a602-e053-2a95a90aca94
Set id: fd256c4a-a176-45dc-b757-fc01eb105008
Version: 8
Effective Time: 20210120
 
McKesson Corporation dba SKY Packaging