ASPIRIN ADULT LOW STRENGTH- aspirin tablet, delayed release 
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

Do not use

  •  if you have ever had an allergic reaction to 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:

  • anticoagulation (thinning of the blood)
  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • 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
  • 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 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

Other information

Inactive ingredients

*acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron
oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate. *May also contain.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Compare to the active ingredient in ASPIRIN REGIMEN BAYER® 81 mg**

SEE NEW WARNINGS INFORMATION

Low Dose 81 mg

ASPIRIN

adult low strength

Pain reliever (NSAID)*

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

**This product is not manufactured or distributedby Bayer Corporation Consumer care division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg

Product Label

Valu merchandisers Best Choice

Enteric coated Aspirin 81 mg

ASPIRIN  ADULT LOW STRENGTH
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-440
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize10mm
FlavorImprint Code E;HEART;81
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-440-121 in 1 CARTON
1120 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34307/26/2010
Labeler - Valu Merchandisers Company (Best Choice) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
Document Id: 8244057c-8522-4871-8576-a15b9583cbb7
Set id: 0025eb89-590c-4451-8a06-b129686cf75a
Version: 2
Effective Time: 20121114
 
Valu Merchandisers Company (Best Choice)