Label: ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG tablet

  • NDC Code(s): 0363-1320-12, 0363-1320-23, 0363-1320-80
  • Packager: WALGREENS CO.
  • 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 September 24, 2019

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

  • ACTIVE INGREDIENT

    Acetaminophen 250mg

    Aspirin 250mg

    Caffeine 65mg

  • INACTIVE INGREDIENT

    ammonium hydroxide, black iron oxide, brilliant blue FCF, corn starch, D&C yellow No. 10 lake, ethyl cellulose, FD&C blue No. 1 lake, FD&C red No. 40 lake, gelatin, glycerin, hydroxypropyl methyl cellulose, lactose monohydrate, light liquid paraffin, microcrystalline cellulose, povidone, pregelatinised starch, propylene glycol, shellac glaze, sorbitol sorbitan, stearic acid, talc, titanium dioxide, triacetin.

  • DOSAGE & ADMINISTRATION

    • Do not use more than directed
    • Drink a full glass of water with each dose
    • Adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours
    • Children under 12 years: ask a doctor

  • INDICATIONS & USAGE

    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 geltabs in 24 hours, which is the maximum daily amount, with other drugs contains acetaminophen, 3 or more alcoholic drinks every day while using this product.

    Stomach bleeding warning: This contains an NSAID, which mat 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 product, take more or for a longer time than direct.

    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, 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 are taking a diuretic, you have asthma.

    Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis, any other drug, or are under a doctor’s care for any serious condition.

    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.

    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 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

    Keep out of reach of children.

    OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Pain reliever

    Pain reliever

    Pain reliever aid

  • OTHER SAFETY INFORMATION

    • Store at room temperature between 20-25 ºC (68-77 ºF)
    • Avoid excessive heat, cold, and humidity
    • Close cap tightly after use
    • Read all product information before using. Keep box for important information.
  • PRINCIPAL DISPLAY PANEL

    CT32023CT32080CT32012LB32023LB32080LB32012

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG 
    acetaminophen 250mg aspirin 250mg caffeine 65mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1320
    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
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    TALC (UNII: 7SEV7J4R1U)  
    SHELLAC (UNII: 46N107B71O)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorgreen (Dark Green - White) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code S77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1320-12120 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2019
    2NDC:0363-1320-8080 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2019
    3NDC:0363-1320-2320 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/24/2019
    Labeler - WALGREENS CO. (008965063)