Label: XPECT PAIN AWAY- pain reliever tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 31, 2021

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

  • 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
    • 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 heart beat.
    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 to not 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • INDICATIONS & USAGE

    Temporarily relieves minor aches and pains due to:
    • headache
    •a cold
    •arthritis
    •muscular aches
    •sinusitis
    •toothache
    •premenstrual & menstrual cramps

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • Purposes

    Active ingredients (in each tablet)
    Acetaminophen 250 mg……………..Pain reliever
    Aspirin 250 mg (NSAID)*…………..Pain reliever
    Caffeine 65 mg………………………Pain reliever aid

  • Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take two tablets every 6 hours; not more than 8 tablets in 24 hours
    • children under 12 years: ask a doctor

  • ACTIVE INGREDIENT

    Acetaminophen 250 mg……………..Pain reliever
    Aspirin 250 mg (NSAID)*…………..Pain reliever
    Caffeine 65 mg………………………Pain reliever aid
    *nonsteroidal anti-inflammatory drug

  • INACTIVE INGREDIENT

    hydroxypropyl methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

  • Other Information

    • store at controlled room temperature 20-25C (68-77F)
    • read all product information before using. Keep this box for important information.

  • PRINCIPAL DISPLAY PANEL

    Pain Away Label

  • INGREDIENTS AND APPEARANCE
    XPECT PAIN AWAY 
    pain reliever tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-202
    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
    HYDROXYPROPYL METHACRYLATE (UNII: UKW89XAX2X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 250 (UNII: 5246R0812J)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-202-02100 in 1 BOX02/27/2021
    1NDC:42961-202-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07579402/27/2021
    Labeler - Cintas Corporation (056481716)
    Registrant - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    UltraTab Laboratories151051757manufacture(42961-202)