Label: ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet
- NDC Code(s): 57237-348-01
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 6, 2025
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- Official Label (Printer Friendly)
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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 - PURPOSE
- 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:
- 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 caplets 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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
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
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- any new symptoms occur. These could be signs of a serious condition
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
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Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours.
- children under 12 years: ask a doctor
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- close cap tightly after use
- read all product information before using.
- Inactive ingredients
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
acetaminophen, aspirin and caffeine tabletProduct 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)

