Label: THRULIFE EXTRA STRENGTH HEADACHE RELIEF - acetaminophen, aspirin, caffeine tablet

  • NDC Code(s): 52605-014-01
  • Packager: Polygen Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 12, 2012

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

  • Active ingredient(s)

    (in each caplet)                                  
    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug
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  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid
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  • Use(s)

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

    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 heartbeat.

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  • 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.
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  • 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 heart burn ·you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ·you are taking a diuretic ·you have asthma Close
  • Ask a doctor or pharmacist before use if

    • a prescription drug fordiabetes,  gout,  arthritis
    • any other drug containing an NSAID (prescription or nonprescription) · a blood thinning (anticoagulant)  or steroid drug  ·any other drug, or are under a doctor’s care for any serious condition.
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  • 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:

      · feel faint · vomit blood · have bloody or black stools ·have stomach pain that does not get   better.

    • painful area is red or swollen
    • any few  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

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  • Pregnancy/Breastfeeding

    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.

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  • 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. Close
  • 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 caplets every 6 hours: not more than 8 caplets in 24 hours ·
    • children under  12 years of age: ask a doctor.
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  • Other information

    • store at controlled room temperature 20º-25ºC (68º-77ºF)
    • read all product information before using.
    • use by expiration date on package
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  • Inactive ingredients

    Microcrystalline cellulose, Croscarmellose sodium, Stearic acid, Hypromellose, Traicetin, Titanium dioxide & Talc Close
  • Dosage & Administration section

    • Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 8 caplets in 24 hours.
    • Children under 12 years: ask a doctor
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  • OTC - Questions section

    1-888-291-7337 Close
  • Principal Display Panel

    Bottle label PDP

    EXTRA STRENGTH HEADACHE RELIEF

    Bottle Label PDP




    Carton label PDP

    EXTRA STRENGTH HEADACHE RELIEF

    Carton label PDP


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  • INGREDIENTS AND APPEARANCE
    THRULIFE EXTRA STRENGTH HEADACHE RELIEF 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-014
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code P14
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52605-014-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 01/31/2013
    Labeler - Polygen Pharmaceuticals LLC (962415720)
    Establishment
    Name Address ID/FEI Business Operations
    Polygen Pharmaceuticals LLC 962415720 RELABEL(52605-014) , REPACK(52605-014) , MANUFACTURE(52605-014) , PACK(52605-014)
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