ACETAMINOPHEN, ASPIRIN AND CAFFEINE- acetaminophen, aspirin and caffeine tablet 
Rising Pharma Holdings, Inc.

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Compare to active ingredients in EXCEDRIN® EXTRA STRENGTH+

EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
250 mg/250 mg/65 mg

Pain Reliever/ Pain Reliever Aid

100 Caplets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Drug Facts

Active ingredients (in each caplet)                                                          Purposes
Acetaminophen USP, 250 mg...............................................................Pain reliever
Aspirin USP, 250 mg (NSAID*).............................................................Pain reliever
Caffeine USP, 65 mg........................................................................Pain reliever aid
*nonsteroidal anti-inflammatory drug

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 sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat.

Do not use

Ask a doctor before use if 

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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.

Directions

Other information

Inactive ingredients

Colloidal silicon dioxide , hypromellose, microcrystalline cellulose , polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc

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

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816Made in IndiaMfg. Lic. No.: G/25/1362

Issued: 09/2025
S-066


+This product is not manufactured or distributed by the owner of the registered trademark Excedrin® Extra Strength

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine
250mg/250mg/65mg

NDC 57237-348-01

100 Caplets

aceta-asp-caff-caplets

ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-348
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorwhite (Off White) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code S7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-348-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/09/2025
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 (915664486)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Ltd863182240label(57237-348) , pack(57237-348)
Establishment
NameAddressID/FEIBusiness Operations
Elysium Pharmaceuticals Ltd915664486manufacture(57237-348) , analysis(57237-348)

Revised: 10/2025
Document Id: 607f9cfd-3a13-4597-b7e9-70a3377fc1d6
Set id: 50f72713-50f5-4bab-9e96-b9fa73c9df1f
Version: 2
Effective Time: 20251006
 
Rising Pharma Holdings, Inc.