ADULT LOW DOSE ASPIRIN ENTERIC COATED- aspirin 81mg tablet, delayed release 
Pharbest Pharmaceuticals, 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)

Aspirin 81mg (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
  • if you have ever had an allergic reaction to this product or any of its ingredients

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:

  • 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
  • an allergic reaction occurs. Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

 Adults and children 12 years and over take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
 Children under 12 years consult a doctor

Other information

Inactive ingredients

croscarmellose sodium, D&C Yellow# 10 Lake, FD&C Yellow #6, hypromellose, lactose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

(866) 562-2756 Mon - Fri 8 AM to 4 PM 

PHARBEST

NDC 16103-351-11

Manufactured in the USA

*Compare to the active ingredient in Bayer® Low Dose

Adult Low Dose

Aspirin

ENTERIC COATED

81mg

Aspirin 81 mg

Pain Reliever (NSAID)

EA8

1000 TABLETS

Talk to you doctor or other healthcare provider before using this product for your heart.

Adult Low Dose Aspirin Enteric Coated Package Label

ADULT LOW DOSE ASPIRIN ENTERIC COATED 
aspirin 81mg tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-351
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Coloryellow (YELLOW COLOR) Scoreno score
ShapeROUND (ROUND TABLET) Size7mm
FlavorImprint Code EA8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-351-09120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
2NDC:16103-351-16300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
3NDC:16103-351-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/20/2019
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-351) , pack(16103-351) , analysis(16103-351) , label(16103-351)

Revised: 2/2019
Document Id: 861d9dec-08f5-4a50-979a-188ac3859e6e
Set id: 45e5bae9-22a7-4699-85ea-5b922af6b96d
Version: 2
Effective Time: 20190220
 
Pharbest Pharmaceuticals, Inc.