ASPIRIN 325 MG EC- aspirin tablet 
Denton Pharma, Inc. dba Northwind Pharmaceuticals

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 325 MG EC TABLET

Drug Facts

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Reliever/Fever Reducer

temporarily relieves

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 prodcut, 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

Stomach bleeding warning: This prodcut contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Drug Facts continued on back of label

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

• feel faint

• vomit blood

• have bloody or black stools

• have stomach pain that does not get better

These could be sings of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Other information

Inactive ingredients

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Principal Display Panel

NDC: 70934-561-90

label

ASPIRIN 325 MG EC 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70934-561(NDC:69618-015)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code AP;110
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70934-561-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/05/2020
Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals080355546repack(70934-561)

Revised: 5/2020
Document Id: ac25f463-dd9d-325a-e053-2995a90a27f1
Set id: ac25f45a-bfa6-71ce-e053-2a95a90a02ec
Version: 1
Effective Time: 20200505
 
Denton Pharma, Inc. dba Northwind Pharmaceuticals