EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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  • EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

EXCEDRIN EXTRA STRENGTH GELTABS (ACETAMINOPHEN, ASPRIN, CAFFEINE) TABLET, COATED [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
PDF | XML
NDC 0067-2021-20, 0067-2021-24, 0067-2021-80
Set ID 11a8439b-0159-4351-b0f5-fe7fad6a33c0
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredients (in each GelTab)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever

    Pain reliever

    Pain reliever aid

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    headache
    •
    a cold
    •
    arthritis
    •
    muscular aches
    •
    toothache
    •
    premenstrual & 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 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 heart beat.

    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 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 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. 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
    •
    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
  • Other information

    •
    store at 20°-25°C (68°-77°F)
    •
    close cap tightly after use
    •
    read all product information before using. Keep this box for important information.
  • Inactive ingredients

    benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide

  • Questions?

    1-800-452-0051

  • Principal Display Panel

    NDC 0067-2021-20

    EXCEDRIN

    EXTRA STRENGTH

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain Reliever/Pain Reliever Aid

    20 GELTABS

    TAMPER-EVIDENT BOTTLE

    DO NOT USE IF INNER FOIL SELA IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by: GSK Consumer Healthcare

    Warren, NJ 07059

    ©2015 GSK or its licensor.

    Visit us at www.excedrin.com

    46172149

    Excedrin Extra Strength geltabs 20 count carton
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN  EXTRA STRENGTH GELTABS
    acetaminophen, asprin, caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2021
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    MALTITOL (UNII: D65DG142WK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PEPSIN (UNII: GID333S43J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (dark green) , WHITEScoreno score
    ShapeROUNDSize18mm
    FlavorImprint Code E
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-2021-201 in 1 CARTON09/13/2011
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-2021-241 in 1 CARTON09/13/2011
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2021-801 in 1 CARTON09/13/2011
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/13/2011
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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