Label: ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG tablet, film coated

  • NDC Code(s): 71679-307-00, 71679-307-03
  • Packager: Health Pharma USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 8, 2026

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Active ingredient (in each caplet) Purpose

    Acetaminophen 250 mg.......................................................................................................Pain reliever
    Aspirin 250 mg (NSAID)*....................................................................................................Pain reliever
    Caffeine 65 mg..............................................................................................................Pain reliever aid

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Uses

    Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis
    ■ muscular aches ■ sinusitis ■ toothache ■ premenstrual and menstrual cramps

  • Warning

    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: Aspirin
    may cause a severe allergic reaction, which may include: ■ hives ■ shock ■ facial swelling ■ asthma (wheezing).
    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 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 heartbeat.

  • do not use

    Do not use ■if you 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 a doctor before use if you have

    Ask a doctor before use if■ 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 have asthma ■ you are taking a diuretic

  • Ask your doctor or pharmacist before use if you are

    ask your doctor or pharmacist before use if you are■ taking a prescription drug for diabetes, gout, or arthritis ■ taking
    any other drug or are under a doctor's care for any serious condition

  • Stop use and ask doctor if

    Stop use and ask a doctor if■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ have
    bloody or black stools ■ vomit blood ■ have stomach pain that does not get better ■ an allergic reaction occurs. Seek
    medical help right away. ■ any new symptoms appear ■ 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 ■ painful area is red or swollen

  • If pregnant or breast-feeding

    If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin during the 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

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

  • Directions

    Directions

    ■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children
    12 years and over ■ take 2 tablets every 6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12
    years: ask a doctor

  • Other Information

    Other Information
    ■ Store at controlled room temperature 20°-25°C (68°-77°F).
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

    Inactive ingredients:Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone,
    Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, Talc, Hypromellose,Purified water

  • Questions or comments?

    Questions or comments?
    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

  • PRINCIPAL DISPLAY PANEL

    71679-307-00-Bulk Label71679-307-03-ES Headache Relief-APAP-Aspirin-Caffeine-300s-7.5x3-300cc Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MG 
    acetaminophen 250 mg aspirin 250 mg caffeine 65 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-307
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ACETAMINOPHEN (UNII: 362O9ITL9D) 250 mg
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code HH6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71679-307-0030000 in 1 DRUM; Type 0: Not a Combination Product03/07/2024
    2NDC:71679-307-03300 in 1 BOTTLE; Type 0: Not a Combination Product03/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/07/2024
    Labeler - Health Pharma USA LLC (080804485)
    Registrant - Health Pharma USA LLC (080804485)