SAFETY COATED ASPIRIN- aspirin tablet 
Valu Merchandisers Company (Best Choice)

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)

Aspirin 81 mg (NSAID)*

*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 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 any other pain reliever/fever reducer 

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 are taking a diuretic 
  • you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis 

Stop use and ask a doctor if

  • you experienece 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
    • allergic reaction occurs
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • any new symptoms appear
    • redness or swelling is present in the painful area

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 the 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

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C Red # 40 Aluminum lake,FD&C Yellow # 6 Aluminum Lake,  iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,  simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

Questions or comments?

call toll free 1-877-753-3935

Principal Display Panel

Compare to the active ingredient in St. Joseph® Aspirin 

This product is not manufactured or distributed by McNeil Consumer & Speciality Pharmaceuticals, owner of the registered trademark ST. JOSEPH® 81 mg

See New Warnings Information

SAFETY COATED ASPIRIN

Adult Low Strength, 81 mg (NSAID)* Aspirin Regimen**

**Ask your doctor before taking this product on a regular basis

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Valu Merchandisers BEST CHOICE

Enteric coated Aspirin 81 mg

SAFETY COATED ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-441
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE (enteric coated peach) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code heart;328
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-441-011 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/21/2010
Labeler - Valu Merchandisers Company (Best Choice) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
Document Id: c7e09164-cdab-4aef-a813-2c02ede6a49d
Set id: 1fe911d3-4e7d-4af1-87e9-9657f91e4f83
Version: 1
Effective Time: 20121121
 
Valu Merchandisers Company (Best Choice)