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 July 3, 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
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
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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
- 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
- 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
- Keep out of reach of children.
-
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
- 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)

