Label: ACETAMINOPHEN, ASPIRIN AND CAFFEINE tablet

  • NDC Code(s): 62207-680-47, 62207-680-51, 62207-680-98, 62207-680-99
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 16, 2021

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

  • ACTIVE INGREDIENT(S)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Pain reliever

    Pain reliever

    Pain reliever aid

  • USE(S)

    • 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 caplets 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

    • taking a prescription drug for:

    o diabetes

    o gout

    o 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 DOCTOR IF

    • an allergic reaction occurs. Seek medical help right away.

    • you experience any of the following signs of stomach bleeding :

    o feel faint

    o vomit blood

    o have bloody or black stools

    o 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 caplets with a glass of water

    • if symptoms persist or worsen, ask your doctor

    • do not take more than 2 caplets in 24 hours, unless directed by a doctor

    • under 18 years of age: ask a doctor

  • OTHER INFORMATION

    • store at controlled room temperature 20° to 25°C (68° to 77°F)

    • close cap tightly after use

    • read all product information before using. Keep this box for important information.

    • Tamper Evident : Do not use if foil inner seal under the cap is opened or missing

  • INACTIVE INGREDIENTS

    Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, sodium stearyl fumarate and titanium dioxide

  • QUESTIONS OR COMMENTS?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST



    Manufactured by:

    Granules India Limited

    Hyderabad-500 043, India

    MADE IN INDIA



    Distributed By:

    Granules USA, Inc.

    Parsippany, NJ 07054

  • PRINCIPAL DISPLAY PANEL

    apap-aspirin-10s-cartonlabel-jpg

    apap-aspirin-10slabel-jpg

    apap-aspirin-500slabel-jpg

  • PRINCIPAL DISPLAY PANEL

    apap-asprin-bulk-label-1-jpg

  • PRINCIPAL DISPLAY PANEL

    apap-asprin-bulk-label-2-jpg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, ASPIRIN AND CAFFEINE 
    acetaminophen, aspirin and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-680
    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
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (Capsule shaped Tablet) Size17mm
    FlavorImprint Code I1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-680-511 in 1 CARTON04/15/2021
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-680-47500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    3NDC:62207-680-9822500 in 1 BOX; Type 0: Not a Combination Product04/15/2021
    4NDC:62207-680-994500 in 1 POUCH; Type 0: Not a Combination Product04/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21403904/15/2021
    Labeler - Granules India Ltd (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236analysis(62207-680) , label(62207-680) , manufacture(62207-680) , pack(62207-680)