REGULAR STRENGTH ASPIRIN EC  - aspirin tablet, delayed release 
H.J. Harkins Company, Inc.

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 (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses

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

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 (1-800-222-1222).

Directions

Other information

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

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444

IMAGE OF BOTTLE LABEL
REGULAR STRENGTH ASPIRIN EC  
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-018(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)  
CELLULOSE, MICROCRYSTALLINE (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:52959-018-1414 in 1 BOTTLE
2NDC:52959-018-2020 in 1 BOTTLE
3NDC:52959-018-2424 in 1 BOTTLE
4NDC:52959-018-3030 in 1 BOTTLE
5NDC:52959-018-4040 in 1 BOTTLE
6NDC:52959-018-6060 in 1 BOTTLE
7NDC:52959-018-8080 in 1 BOTTLE
8NDC:52959-018-00100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/09/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - Major Pharmaceuticals Inc (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Labs Inc037052099manufacture

Revised: 12/2011
Document Id: b761ebd8-e9bb-46d1-9671-8e59373f51f6
Set id: 3c15ae1b-c88c-4e04-812d-91a57e77250f
Version: 2
Effective Time: 20111220
 
H.J. Harkins Company, Inc.