Label: ACETAMINOPHEN, ASPIRIN, CAFFEINE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 19, 2021

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

  • Drug Facts

    Active ingredients (in each caplet)
    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID*)
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purposes

    Pain reliever
    Pain reliever aid

  • Uses

    ■ temporarily relieves minor aches and pains due to:
    ■ headache

    ■ muscular aches

    ■ a cold

    ■ arthritis
    ■ toothache

    ■ premenstrual and 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: Aspirin may cause a severe allergic reaction, which may include: ■ hives ■ facial swelling ■ shock ■ asthma (wheezing)
    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.
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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
    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

    ■ 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 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 have asthma

    ■ you are taking a diuretic

    Ask a 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 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.
    ■ 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

    ■ any new symptoms appear.
    These could be signs of a serious condition.

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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
    ■ 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)

    ■ use by expiration date on package

  • INACTIVE INGREDIENT

    hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Acetaminophen, Aspirin, Caffeine

    GENERIC: Acetaminophen, Aspirin, Caffeine

    DOSAGE: TABLET, FILM COATED

    ADMINSTRATION: ORAL

    NDC: 70518-3242-0

    COLOR: white

    SHAPE: OVAL

    SCORE: No score

    SIZE: 17 mm

    IMPRINT: 2793

    PACKAGING: 24 in 1 BOTTLE, PLASTIC

    ACTIVE INGREDIENT(S):

    • CAFFEINE 65mg in 1
    • ASPIRIN 250mg in 1
    • ACETAMINOPHEN 250mg in 1

    INACTIVE INGREDIENT(S):

    • POLYDEXTROSE
    • STEARIC ACID
    • MICROCRYSTALLINE CELLULOSE
    • POVIDONE K30
    • HYPROMELLOSES
    • TALC
    • TITANIUM DIOXIDE
    • MALTODEXTRIN
    • STARCH, CORN
    • SILICON DIOXIDE
    • MEDIUM-CHAIN TRIGLYCERIDES

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, ASPIRIN, CAFFEINE 
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3242(NDC:0536-1326)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 2793
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-3242-024 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/14/2021
    Labeler - REMEDYREPACK INC. (829572556)