ACETAMINOPHEN ASPIRIN AND CAFFEINE tablet

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]

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE

Analgesic and Antipyretic 

DOSAGE & ADMINISTRATION

FOR MANUFACTURING, PROCESSING OR REPACKING

WARNINGS

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

INACTIVE INGREDIENT

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

PURPOSE

FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN ASPIRIN AND CAFFEINE 
acetaminophen aspirin and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14803-135
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	S53
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14803-135-00	30000 in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/30/2024

Labeler - Elysium Pharmaceutical Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd		915664486	manufacture(14803-135) , analysis(14803-135)