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

  • NDC Code(s): 68016-226-01
  • Packager: Chain Drug Consortium, LLC
  • 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 December 28, 2017

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

  • Active ingredients (in each caplet)

    ACETAMINOPHEN 250 MG

    ASPIRIN 250 MG (nsaid*)

    CAFFEINE 65 MG

    *nonsteroidal anti-inflammatory drug

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  • Purposes

    PAIN RELIEVER - PAIN RELIEVER AID

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  • USES

    • temporarily relieves minor aches and pains
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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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  • DO NOT USE

    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 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

    Ask a doctor or pharmacist before use if you are taking

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

    Stop use and ask a 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
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear

    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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    Overdose Warning: Taking more than the recommended dose
    (overdose) may cause liver damage. 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.

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  • Directions

    • do not use more than directed (see overdose warning)
    • 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: ask a doctor
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  • INACTIVE INGREDIENTS

    carnauba wax, cellulose,
    hypromellose, mineral oil, povidone, silica, sodium starch
    glycolate, starch, stearic acid, titanium dioxide

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  • Other information

    • store at room temperature 15°- 25°C (59°- 77°F)
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  • Package label
  • INGREDIENTS AND APPEARANCE
    EXTRA PAIN RELIEVER 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-226
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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:68016-226-01 1 in 1 CARTON 07/01/2015
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 07/01/2015
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Geri-Care Pharmaceutical Corp 611196254 repack(68016-226)
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