acetaminophen aspirin and caffeine

acetaminophen aspirin and caffeine by

Drug Labeling and Warnings

acetaminophen aspirin and caffeine by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceutical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACETAMINOPHEN ASPIRIN AND CAFFEINE- acetaminophen aspirin and caffeine tablet 
Elysium Pharmaceutical Ltd

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acetaminophen aspirin and caffeine

KEEP OUT OF THE REACH OF CHILDREN

Analgesic and Antipyretic 

FOR MANUFACTURING, PROCESSING OR REPACKING

KEEP OUT OF THE REACH OF CHILDREN,REMOVE SILICA GEL BAG BEFORE USE

Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone, Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, talc, Hypromellose

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

PRINCIPAL DISPLAY PANEL

label

ACETAMINOPHEN ASPIRIN AND CAFFEINE 
acetaminophen aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 14803-135
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 14803-135-0030000 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/30/2024
Labeler - Elysium Pharmaceutical Ltd (915664486)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceutical Ltd915664486manufacture(14803-135) , analysis(14803-135)

Revised: 1/2026
Document Id: 49715a86-f118-2f36-e063-6394a90a0908
Set id: 1031c81e-ac26-4068-e063-6394a90a6e9d
Version: 4
Effective Time: 20260128