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

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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

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.

Other information

Inactive ingredients

Colloidal silicon dioxide, Croscarmellose sodium, Colloidal silicon dioxide, 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?

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Aspica 81 mg

ASPICA (ASPIRIN) 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49638-101-121 in 1 CARTON09/16/2020
1120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/16/2020
Labeler - America Medic & Science, LLC (071065464)
Registrant - America Medic & Science, LLC (071065464)
Establishment
NameAddressID/FEIBusiness Operations
Invahealth116840615manufacture(49638-101) , analysis(49638-101) , pack(49638-101)

Revised: 1/2024
Document Id: 0f1840de-a91f-a524-e063-6294a90af50f
Set id: 9ca411d6-bfaf-4ed3-ae01-c30520aa5bbd
Version: 4
Effective Time: 20240116
 
America Medic & Science, LLC