LOW DOSE ASPIRIN- aspirin tablet, coated 
Akron Phama

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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Aspirin

Low Dose

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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:  Asiprin may cause a severe allergic reaction, which may include:

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

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow#10 al lake, FD&C yellow#6 al lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?  Call toll-free 1-877-225-6999

Monday to Friday 9AM to 5PM

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LOW DOSE ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8627
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 YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize6mm
FlavorImprint Code A1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-8627-11000 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
2NDC:71399-8627-2120 in 1 BOTTLE; Type 0: Not a Combination Product05/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/12/2021
Labeler - Akron Phama (067878881)

Revised: 2/2023
Document Id: 0bebdf25-4ba1-45b7-b37e-a8c0085de205
Set id: cfe9dc65-dfbb-4c36-a8c9-57bb460a8d97
Version: 2
Effective Time: 20230204
 
Akron Phama