ACETAMINOPHEN- acetaminophen tablet, film coated 
Rising Pharma Holdings, Inc.

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Compare to active ingredient in Tylenol® Extra Strength

Extra Strength
Acetaminophen
500 mg

* Pain Reliever
* Fever Reducer
* Contains No Aspirin

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Drug Facts

Active Ingredient (in each caplet)                                    Purpose

Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer

Uses

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical
attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

aceta-500mg-directions

Other information

Inactive ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments? Call 1-844-474-7464

†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.

Distributed by:
Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

Acetaminophen

500 mg

NDC 57237-347-05

500 Film Coated Caplets

aceta-500mg-500ct

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (Off White) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code S500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-347-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
2NDC:57237-347-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/04/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/09/2025
Labeler - Rising Pharma Holdings, Inc. (116880195)
Registrant - Elysium Pharmaceuticals Ltd (863182240)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Ltd863182240analysis(57237-347) , label(57237-347) , manufacture(57237-347) , pack(57237-347)

Revised: 10/2025
Document Id: ffbb6e36-399b-40eb-96b4-b0406c712c0d
Set id: f8237772-7656-49fb-b1de-f8fcb5fa55ee
Version: 2
Effective Time: 20251028
 
Rising Pharma Holdings, Inc.