Label: ACETAMINOPHEN, ASPIRIN, CAFFEINE tablet, film coated

  • NDC Code(s): 69842-541-06, 69842-541-17
  • Packager: CVS Pharmacy, Inc.
  • 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 June 5, 2018

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

    Purpose

    Pain reliever

    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.

    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?

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

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

    †This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin® Extra Strength Caplets.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-34571

  • PRINCIPAL DISPLAY PANEL

    Value Size 300 Caplets

    CVSHealth

    Compare to the active ingredients in Excedrin® Extra Strength Caplets†

    EXTRA STRENGTH Headache Relief

    ACETAMINOPHEN, ASPIRIN (NSAID)* & CAFFEINE

    Pain reliever ; Pain reliever aid

    300 Caplets

    5004-label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, ASPIRIN, CAFFEINE 
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-541
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 2793
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-541-06200 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
    2NDC:69842-541-17300 in 1 BOTTLE; Type 0: Not a Combination Product06/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/22/2018
    Labeler - CVS Pharmacy, Inc. (062312574)