ASPIRIN 81MG ADULT LOW DOSE- aspirin tablet, delayed release 
PHARMAMED USA INC

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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 alergic 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

Stop use and ask a doctor if:

These could be signs of a serious condition.

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

Other information

Inactive ingredients

croscarmellose sodium, D&C yelow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

Questions? Adverse drug event call:

(866) 562-2756

Package Label Principal Display Panel

PHARMAMED

NDC 84289-356-12

Manufactured in the U.S.A

Pain Reliever (NSAID) / Adult Low Dose

Aspirin

Aspirin 81mg

120 TABS

ENTERIC COATED

Aspirin Regimen

*Compare to the active ingredient in BAYER Low dose

Label Image

ASPIRIN 81MG ADULT LOW DOSE 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84289-356(NDC:16103-356)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code PH023
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84289-356-12120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2024
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)10/01/2024
Labeler - PHARMAMED USA INC (065607328)
Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
PHARBEST PHARMACEUTICALS, INC.557054835repack(84289-356)

Revised: 6/2024
Document Id: 1bcb12ae-b5d8-468e-e063-6294a90a4cfa
Set id: 1b2e6566-cb7c-7a7d-e063-6394a90af97c
Version: 2
Effective Time: 20240626
 
PHARMAMED USA INC