ASPIRIN- aspirin tablet 
Richmond Pharmaceuticals, Inc.

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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ENTERIC COATED ASPIRIN 81mg

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 these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

Other Information

Inactive Ingredients

croscarmellose sodium, D&C Yellow #10 (Al-Lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, PVP, silicon dioxide, sodium lauryl sulfate, corn starch, stearic acid, talc, titanium dioxide

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safer for your stomach than pain or Buffered Aspirin

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 54738-559-12– 120 Tablets

image2

NDC: 54738-559-25 - 240 Tablets

NDC: 54738-559-03 - 1000 Tablets

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-559
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-559-12120 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
2NDC:54738-559-25250 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
3NDC:54738-559-031000 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-559)

Revised: 11/2017
Document Id: 5cec1103-cec1-0e47-e053-2991aa0a32c5
Set id: 11458142-4953-4f9f-bbb6-4422d085a960
Version: 2
Effective Time: 20171101
 
Richmond Pharmaceuticals, Inc.