REGULAR STRENGTH ENTERIC COATED ASPIRIN- aspirin tablet, coated 
ATLANTIC BIOLOGICALS CORP.

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gc 921

Active ingredient (in each tablet)

Aspirin 325 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 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.

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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 right away.

Directions

Other information

Inactive ingredients

cellulose, D&C yellow
#10 lake, FD&C yellow #6 lake, hypromellose, iron
oxide, PEG, polydextrose, polyvinyl acetate phthalate,
propylene glycol, shellac wax, silica, simethicone,
sodium alginate, sodium bicarbonate, starch, stearic
acid, talc, titanium dioxide, triacetin, triethyl citrate.
May also contain acetylated monoglycerides,
croscarmellose sodium, hypromellose phthalate,
methacrylic acid, mineral oil, polysorbate 80, sodium
lauryl sulfate.

DISTRIBUTED BY: 

ALTANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE 

MIAMI, FL 33179

package label

NDC 17856-0922-1
Regular Strength

ENTERIC COATED ASPIRIN

pain reliever (NSAID)

PACKAGE NOT CHILD RESISTANT

100 Tablets

325 mg each

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

image 1

REGULAR STRENGTH ENTERIC COATED ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0922(NDC:57896-921)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0922-1100 in 1 BOX, UNIT-DOSE04/18/2024
1NDC:17856-0922-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM07/01/2000
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-0922)

Revised: 4/2024
Document Id: 2e9f91e3-1cef-47ea-bb32-d64fadc0bb09
Set id: e1c8d0ed-da1d-4b1a-9a85-7b8532775f87
Version: 3
Effective Time: 20240418
 
ATLANTIC BIOLOGICALS CORP.