Home > Pill Identifier > Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet

Pill Identifier Information of Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet

Drug Information

Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet

Imprint: E
Shape: C48348
Color: C48329;C48325
Ingredients: Acetaminophen; Aspirin; Caffeine
Size: 18.00
Score: 1
Rxtty: SY
Author: Novartis Consumer Health, Inc
Inactive Ingredients: BENZOIC ACID / D&C YELLOW NO. 10 / EDETATE DISODIUM / FD&C BLUE NO. 1 / FD&C RED NO. 40 / FERRIC OXIDE RED / GELATIN / GLYCERIN / HYDROXYPROPYL CELLULOSE / HYPROMELLOSES / LIGHT MINERAL OIL / MALTITOL / CELLULOSE, MICROCRYSTALLINE / POLYSORBATE 20 / POVIDONE / PROPYLENE GLYCOL / PROPYL GALLATE / DIMETHICONE / SORBITAN MONOLAURATE / STEARIC ACID / TITANIUM DIOXIDE>

Complete Information

  • 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

  • Use

    • treats migraine
  • 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 2 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

    Medication overuse headache warning:Headaches may worsen if this product is used for 10 or more days per month.

    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 never had migraines diagnosed by a health professional
    • you have a headache that is different from your usual migraines
    • you have the worst headache of your life
    • you have fever and stiff neck
    • you have headaches beginning after or caused by head injury, exertion, coughing or bending
    • you experienced your first headache after the age of 50
    • you have daily headaches
    • you have a migraine so severe as to require bed rest
    • 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
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have vomiting with your migraine headache

    Ask a doctor or pharmacist before use if you are
    • taking a prescription drug for:
      • diabetes
      • gout
      • arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

    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
    • your migraine is not relieved or worsens after first dose
    • new or unexpected symptoms occur
    • ringing in the ears or loss of hearing occurs

    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
    • adults: take 2 geltabs with a glass of water
    • if symptoms persist or worsen, ask your doctor
    • do not take more than 2 geltabs in 24 hours, unless directed by a doctor
    • under 18 years of age: ask a doctor
  • Other information

    • store at controlled room temperature 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, disodium EDTA, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, ferric oxide, gelatin, glycerin, hydroxypropylcellulose, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, maltitol solution, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

  • Questions?

    1-800-452-0051

  • Principal Display Panel

    0067-2035-20

    See new warnings information

    Excedrin®

    Migraine

    Acetaminophen, Aspirin (NSAID) and Caffeine

    Pain reliever / Pain Reliever Aid

    20GELTABS*

    *GELATIN COATED TABLETS

    TAMPER-EVIDENT BOTTLE

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

    Distributed by: GSK Consumer HealthcareWarren, NJ 07059

    ©2017 GSK or its licensor.

    Visit us at www.excedrin.com

    62000000012939

    62000000012939_Excedrin Geltabs_20 ct.JPG
  • INGREDIENTS AND APPEARANCE
    EXCEDRIN   MIGRAINE GELTABS
    acetaminophen, asprin, caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2035
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    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:0067-2035-201 in 1 CARTON09/13/2011
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-2035-241 in 1 CARTON09/13/201112/31/2014
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0067-2035-501 in 1 CARTON09/13/201112/31/2014
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0067-2035-801 in 1 CARTON09/13/2011
    480 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0067-2035-912 in 1 CARTON09/13/201112/31/2014
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0067-2035-162 in 1 CARTON09/13/201112/31/2014
    6160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02080209/13/2011
    Labeler - Haleon US Holdings LLC (079944263)
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