REGULAR STRENGTH ASPIRIN EC- aspirin tablet, delayed release 
Major 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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Drug Facts

Active ingredient

Active ingredient (in each tablet)                  Purpose
 
Aspirin 325 mg (NSAID*).............................Pain reliever
 
*nonsteroidal anti-inflammatory drug

Purpose

 
Purpose
Pain reliever

Uses

Uses
o
for the temporary relief of minor aches and pains due to
 
 
headache
colds
muscle pain
menstrual pain
toothache
minor pain of arthritis
o
or as directed by your doctor

Warnings

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 or 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:
o
hives
o
facial swelling
o
shock
o
asthma (wheezing)
 
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
o
are age 60 or older
o
have had stomach ulcers or bleeding problems
o
take a blood thinning (anticoagulant) or steroid drug
o
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
o
have 3 or more alcoholic drinks every day while using this product
o
take more or for a longer time than directed

Do Not Use

Do not use
o
if you are allergic to aspirin or any other pain reliever/fever reducer

Ask Doctor

Ask a doctor before use if
o
stomach bleeding warning applies to you
o
you have a history of stomach problems, such as heartburn
o
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
o
you are taking a diuretic
o
you have asthma
o
you have not been drinking fluids

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are
o
taking a prescription drug for diabetes, gout, or arthritis
o
taking any other drugs
o
under a doctor's care for any serious condition

Stop Use

Stop use and ask a doctor if
o
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
o
pain gets worse or lasts more than 10 days
o
fever gets worse or lasts more than 3 days
o
redness or swelling is present in the painful area
o
any new symptoms appear
o
ringing in the ears or a loss of hearing occurs

Pregnancy or Breast Feeding

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.

Directions

Directions
o
drink a full glass of water with each dose
o
adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
o
children under 12 years: consult a doctor

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Storage and Handling

Other information
o
store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
o
use by expiration date on package

Inactive Ingredients

Inactive ingredients 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

Questions

Questions? To Report Adverse Drug Event Call: (800) 616-2471

Package/Label Principal Display Panel

Aspirin EC

325 mg

100 Tablets

bottle label
REGULAR STRENGTH ASPIRIN EC 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-2013-60100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/201102/28/2021
2NDC:0904-2013-72300 in 1 BOTTLE; Type 0: Not a Combination Product09/09/201104/30/2020
3NDC:0904-2013-801000 in 1 BOTTLE; Type 0: Not a Combination Product09/09/201106/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/09/201102/28/2021
Labeler - Major Pharmaceuticals (191427277)

Revised: 10/2019
 
Major Pharmaceuticals