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 Rising Pharma Holdings, Inc., Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR IMPORTANT INFORMATION. Drug Facts

Active ingredients (in each tablet)                                                          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

PURPOSE

Uses

• temporarily relieves minor aches and pains due to:
• headache 
• a cold
• arthritis 
• muscular aches
• toothache
• premenstrual & menstrual cramps

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:

• skin reddening
• blisters
• rash. If a skin reaction occurs, stop use and seek medical help right away.

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

• hives 
• facial swelling 
• asthma (wheezing)
•  shock.

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

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen 
• 3 or more alcoholic drinks every day while using this product.

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

• are age 60 or older 
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug 
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 
• have 3 or more alcoholic drinks every day while using this product. 
• take more or for a longer time than directed.

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

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

ASK DOCTOR

Ask a doctor before use if 

• you have liver disease 
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 
• you are taking a diuretic 
• you have asthma

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for:
• diabetes 
• gout 
• arthritis 
• taking any other drug, or are under a doctor's care for any serious condition 
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer.

STOP USE

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools 
• have stomach pain that does not get better 
• fever gets worse or lasts for more than 3 days 
• new or unexpected symptoms occur 
• ringing in the ears or loss of hearing occurs.

PREGNANCY OR BREAST FEEDING

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

• do not use more than directed
• adults: take 2 tablets with a glass of water
• if symptoms persist or worsen, ask your doctor 
• do not take more than 8 tablets in 24 hours, unless directed by a doctor
• under 18 years of age: ask a doctor

Other information

• store at controlled room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using.

Inactive ingredients

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

QUESTIONS

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

Distributed by:
Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/1362

Issued: 06/2025
S-066

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen, Aspirin (NSAID*) and Caffeine Tablets USP, 250mg/250mg/65mg

NDC: 57237-348-01

100 Tablets

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
acetaminophen, aspirin and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-348
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) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Off White)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	S7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-348-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/09/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Elysium Pharmaceuticals Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	label(57237-348) , pack(57237-348)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	manufacture(57237-348) , analysis(57237-348)