EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [APACE PACKAGING, LLC]

EXTRA PAIN RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [APACE PACKAGING, LLC]
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NDC 15338-703-05, 15338-703-11
Set ID 7a92a39a-5c6e-483b-e053-2991aa0abc2a
Category HUMAN OTC DRUG LABEL
Packager Apace Packaging, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENTS

    ACETAMINOPHEN 250 MG

    ASPIRIN 250 MG (nsaid*)

    CAFFEINE 65 MG
    * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

  • INACTIVE INGREDIENTS

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

  • PURPOSE

    PAIN RELIEVER - PAIN RELIEVER AID

  • 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 .

  • USES

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

  • 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.

  • 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.

  • 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

  • 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.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 50268-053-15
    EXTRA PAIN RELIEF
    Acetaminophen, Aspirin (NSAID) and Caffeine
    EXTRA STREGTH
    50 Tablets (5 X 10) Unit Dose

    5026805315

    NDC 50268-053-15
    EXTRA PAIN RELIEF
    Acetaminophen, Aspirin (NSAID) and Caffeine
    EXTRA STREGTH
    50 Tablets (5 X 10) Unit Dose

    5026805315

    label 1
    label 2
    label 3
  • INGREDIENTS AND APPEARANCE
    EXTRA PAIN RELIEF 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15338-703(NDC:49483-370)
    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
    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
    ColorwhiteScoreno score
    ShapeCAPSULE (CAPSULE SHAPED TABLET) Size18mm
    FlavorImprint Code TCL370
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15338-703-0550 in 1 BOX, UNIT-DOSE08/23/2016
    1NDC:15338-703-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/23/2016
    Labeler - Apace Packaging, LLC (361961142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc.037052099manufacture(15338-703)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apace Packaging, LLC361961142repack(15338-703) , label(15338-703)

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