Label: EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated

  • NDC Code(s): 49483-370-00, 49483-370-01, 49483-370-20
  • Packager: TIME CAP LABS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 22, 2016

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

  • ACTIVE INGREDIENTS

    ACETAMINOPHEN 250 MG

    ASPIRIN 250 MG (nsaid*)

    CAFFEINE 65 MG
    * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

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  • INACTIVE INGREDIENTS

    Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide

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  • PURPOSE

    PAIN RELIEVER - PAIN RELIEVER AID

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  • DIRECTIOINS

    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, NOT MORE THAN 8 TABLETS IN 24 HOURS .

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  • USES

    TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

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  • DO NOT USE

    Do not use if you have ever had an allergic reaction to acetaminophe, 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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  • WARNINGS

    REYE'S SYNDROME:

    Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.

    ALLERY ALERT

    Aspirin may cause a severe allergic reaction which may include:

    hives

    facial swelling

    asthma (sheezing)

    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 usng 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 (anticogulant) or steroid drug

    take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)

    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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

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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 sighs or symptoms

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  • PREGNANCY

    If Pregnant or breast-feeding ask a helth 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 becausde it may cause prombles inthe unborn child or complications during delivery.

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  • INGREDIENTS AND APPEARANCE
    EXTRA PAIN RELIEF 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-370
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white Score no score
    Shape capsule (CAPSULE SHAPED TABLET) Size 18mm
    Flavor Imprint Code TCL370
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-370-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/22/2016
    2 NDC:49483-370-20 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2013
    3 NDC:49483-370-00 20000 in 1 CARTON; Type 0: Not a Combination Product 02/22/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/01/2013
    Labeler - TIME CAP LABS (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    TIME CAP LABS 037052099 manufacture(49483-370)
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