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headache formula (Kroger Company)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BOTTLE in 1 CARTON (30142-430-78) > 100 TABLET, FILM COATED in 1 BOTTLE Label Information

Complete headache formula Information

  • Active ingredient (in each tablet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteriodal anti-inflammatory drug


  • Purpose

    Pain reliever

    Pain reliever aid


  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • sinusitis
    • arthritis
    • a cold
    • 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
    • asthma (wheezing)
    • shock

    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 than directed

    When using this product

    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 heart beat.

    Do not use
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • if you are allergic to aspirin
    • 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
    • arthritis

    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
    • redness or swelling is present
    • any new symptoms occur
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • ringing in the ears or a loss of hearing occurs

    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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 (see Liver warning)
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 tablets every 6 hours; do not exceed 8 tablets in 24 hours
    • children under 12 years: ask a doctor

  • Other information

    store at 20º-25ºC (68º-77ºF)


  • Inactive ingredients

    carnauba wax, crospovidone, FD&C blue no. 1 lake, hypromellose, microcrystalline cellulose**, povidone, propylene glycol, saccharin sodium, starch, stearic acid, titanium dioxide **may contain this ingredient


  • Questions or comments?

    1-800-632-6900


  • Principal Display Panel

    COMPARE TO active ingredients of EXCEDRIN® EXTRA STRENGTH TABLETS

    ***See bottom panel

    ADDED STRENGTH

    SEE NEW WARNINGS INFORMATION

    Headache Formula

    Pain Reliever/Pain Reliever Aid

    Acetaminophen, Aspirin (NSAID) and Caffeine

    For Pain of Headaches, Minor Arthritis and Colds

    Headache Formula Carton Image 1

    Headache Formula Carton Image 1

    Headache Formula Carton Image 2

    Headache Formula Carton Image 1

    Headache Formula Carton Image 2


  • INGREDIENTS AND APPEARANCE
    HEADACHE FORMULA  ADDED STRENGTH
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-430
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code L430
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-430-78 1 in 1 CARTON 01/30/1997
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/30/1997
    Labeler - Kroger Company (006999528)