Label: XPECT PAIN AWAY EXTRA STRENGTH- acetaminophen aspirin caffeine tablet

  • NDC Code(s): 42961-234-01, 42961-234-02, 42961-234-03
  • Packager: Cintas Corporation
  • Category: HUMAN OTC DRUG LABEL

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 July 26, 2023

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  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever

    Pain reliever

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to: • a cold • toothache • headache • muscular aches • arthritis • premenstrual and menstrual cramps 
  • WARNINGS

    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 bahavior with nausea and vomiting occur, consult a doctor becuase 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: • shock • facial swelling • hives • asthma (wheezing)

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening •blisters • rash 

    If a skin reaction occurs, stop use and seek medical help right away. 

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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

    • 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
    • are age 60 or older
    • 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
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • you have liver disease
    • you have asthma
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Ask a doctor or pharmacist before use if you are

    • taking a precription drug for diabetes, gout, or arthritis
    • taking 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 • have bloody or black stools • vomit blood • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur

    These could be signs of a serious condition. 

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take 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. Do not take more than 8 tablets in 24 hours. 
    • children under 12 years: ask a doctor 
  • OTHER SAFETY INFORMATION

    Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see packet for expiration date and lot number 
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide 

  • QUESTIONS

    Questions? 

    1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM

  • Principal Display Panel - 42961-234-02

    †Compare to the active ingredients of Excedrin®

    EXTRA STRENGTH PAIN AWAY®

    Active Ingredients:

    Acetaminophen

    Aspirin (NSAID)

    Caffeine

    Pain Reliever / Pain Reliever Aid

    • Relief from headaches
    • Contains caffeine

    Xpect® First aid

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    100 Tablets • 50 Packets (2 tablets per packet) per Box

    †This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

    111689

    100_Box

  • Principal Display Panel - 42961-234-03

    †Compare to the active ingredients of Excedrin®

    EXTRA STRENGTH PAIN AWAY®

    Active Ingredients:

    Acetaminophen

    Aspirin (NSAID)

    Caffeine

    Pain Reliever / Pain Reliever Aid

    • Relief from headaches
    • Contains caffeine

    Xpect® First aid

    WORKPLACE READY®

    • Single Dose
    • Tamper Evident

    250 Tablets • 125 Packets (2 tablets per packet) per Box

    †This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®.

    111699

    250_Box

  • INGREDIENTS AND APPEARANCE
    XPECT PAIN AWAY EXTRA STRENGTH 
    acetaminophen aspirin caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-234
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-234-0250 in 1 BOX07/26/2023
    1NDC:42961-234-012 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:42961-234-03125 in 1 BOX07/26/2023
    2NDC:42961-234-012 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/26/2023
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    L.N.K. International Inc.832867894manufacture(42961-234)
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