Acetaminophen by Elysium Pharmaceuticals Ltd. / Elysium Pharmaceuticals Limited ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Elysium Pharmaceuticals Ltd., Elysium Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acetaminophen USP 500mg

PURPOSE

for further packing and labelling 

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

WARNINGS

keep out of reach of children and for further packing

INACTIVE INGREDIENT

Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone , Stearic Acid powder,Titanium Dioxide, Talc,

DOSAGE & ADMINISTRATION

anti-inflamatory and for further packing 

INDICATIONS & USAGE

Anti Inflamatory

SPL UNCLASSIFIED SECTION

label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14803-013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14803-013-00	47000 in 1 BOX; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/07/2024

Labeler - Elysium Pharmaceuticals Ltd. (915664486)

Registrant - Elysium Pharmaceuticals Ltd. (863182240)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd.		915664486	manufacture(14803-013) , analysis(14803-013)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Limited		863182240	pack(14803-013) , manufacture(14803-013)