ASPIRIN- aspirin tablet, delayed release 
America Medic & Science, LLC

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.

----------

Aspirin Delayed Release Tablets USP, 81 MG
Low Dose
Safety Coated Aspirin

Aspirin Delayed Release Tablets, USP 81 MG
Low Dose
Safety Coated Aspirin

Drug Facts

Active Ingredient

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 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 your doctor before use

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

Stop use and ask doctor if
an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:

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 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.

Do not use this product if printed safety seal under cap is torn or missing.

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.

Directions

Other information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

Questions or comments?

call 1-855-314-1850

Aspirin Delayed Release Tablets, USP 81 MG

image description

ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-115
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-115-601 in 1 CARTON07/06/2020
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34307/06/2020
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
NameAddressID/FEIBusiness Operations
Elvi Pharma LLC078739246manufacture(49638-115)

Revised: 9/2020
Document Id: 2933c63c-26ab-489c-81cc-723ccd7d6f8a
Set id: e88fe09e-9f3d-4ab2-bf8a-8eafe45a8989
Version: 2
Effective Time: 20200916
 
America Medic & Science, LLC