Label: HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet

  • NDC Code(s): 79903-370-01, 79903-370-20, 79903-370-21
  • Packager: Walmart Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 14, 2024

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

  • Drug Facts

  • ACTIVE INGREDIENT

    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
    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:

    -headache
    -a cold
    -arthritis
    -muscular aches
    -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: 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 heartbeat.

  • DO NOT USE

    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 DOCTOR

    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 are taking a diuretic
    • you have asthma

  • ASK DOCTOR/PHARMACIST

    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

    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
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms occur
    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

  • DOSAGE & ADMINISTRATION

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

  • OTHER SAFETY INFORMATION

    Other information
    • store at 20°- 25°C (68°- 77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package

  • INACTIVE INGREDIENT

    Inactive ingredients
    carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxid

  • QUESTIONS

    Questions or comments? Call 1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    370r-headache-200-label370r-headache-100-label370r-headach-200-ifc

  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-370
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Caplet) Size18mm
    FlavorImprint Code TCL370
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-370-20200 in 1 BOTTLE; Type 0: Not a Combination Product07/30/2024
    2NDC:79903-370-212 in 1 CARTON07/30/2024
    2NDC:79903-370-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/30/2024
    Labeler - Walmart Inc. (051957769)
    Registrant - TIME CAP LABORATORIES INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES INC037052099manufacture(79903-370)