Label: HEADACHE FORMULA ADDED STRENGTH- 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 December 18, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteriodal anti-inflammatory drug

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  • Purpose

    Pain reliever

    Pain reliever aid

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  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    muscular aches
    sinusitis
    arthritis
    a cold
    toothache
    premenstrual and menstrual cramps
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  • 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.

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  • 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
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  • Other information

    store at 20º-25ºC (68º-77ºF)

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  • 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

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  • Questions or comments?

    1-800-632-6900

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  • 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

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  • 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)
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