EXTRA STRENGTH HEADACHE RELIEF TABLET, COATED [HEALTHLIFE OF USA]

EXTRA STRENGTH HEADACHE RELIEF TABLET, COATED [HEALTHLIFE OF USA]
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NDC 69517-105-24
Set ID a0cdc5d6-9995-4424-badd-db74e1e0bc3b
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA
Generic Name
Product Class
Product Number
Application Number PART343
  • Drug Facts

  • Purpose

    Pain reliever, Pain reliever aid

  • Active Ingredient (in each caplet)

    Acetaminophen 250mg

    Aspirin 250mg

    Caffeine 65mg

  • Uses

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

    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

    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, food, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

  • Do not use

    • if you 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 wheather 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 have asthma
    • you are taking a diuretic
  • Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor's care for any serious condition
  • Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • any new symptoms appear
    • ringing in the ears or loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • painful area is red or swollen
  • 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 (1-800-222-1222) 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 tablets every 6 hours
    • Do not take more than 8 tablets in 24 hours
    • Children under 12 years: ask a doctor
  • Other Information

    • Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Corn starch
    • Crospovidone
    • Hypromellose
    • Microcrystalline cellulose
    • Povidone
    • Propylene glycol
    • Sodium Lauryl sulfate
    • Sodium starch glycolate
    • Stearic acid
    • Titanium dioxide
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM- 5PM EST or www.healthlifeofusa.com

  • Extra Strength Headache Relief Acetaminophen 250mg / Pain Reliever Aspirin 250mg (Nsaid) / Pain Reliever Caffeine 65mg / Pain Reliever Aid  24 Caplets Compare to Excedrin® Extra Strength active ingredients 

    Distributed by:
    Healthlife of USA LLC
    Rahway
    NJ 07065
    www.healthlifeofusa.com

    image description

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH HEADACHE RELIEF 
    extra strength headache relief tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-105
    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 
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-105-241 in 1 CARTON05/31/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals limited915664486manufacture(69517-105) , pack(69517-105)