ENTERIC COATED ASPIRIN - regular strength tablet 
A-S Medication Solutions

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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Enteric Coated Aspirin Regular Strength

ACTIVE INGREDIENTS (IN EACH TABLET)

Aspirin 325mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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:

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

Do Not Use

if you are allergic to aspirin or other pain relievers/fever reducers

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:

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • 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, vomit blood, have bloody or black stools, have stomach pain that does not get better
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days

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 specifically 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

You may report serious side effects to: 1-888-952-0050

INACTIVE INGREDIENTS

corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Regular Strength

Label Image
ENTERIC COATED ASPIRIN  
regular strength tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0003(NDC:0603-0169)
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0003-1 30 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
2NDC:50090-0003-3 100 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
3NDC:50090-0003-5 90 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/04/2011
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0003) , REPACK(50090-0003)

Revised: 8/2017
Document Id: 50479dca-be02-4908-b26e-0438baba8f1c
Set id: c284cf77-656f-4b36-a8b4-4839ef347f13
Version: 5
Effective Time: 20170818
 
A-S Medication Solutions