Label: PAIN TERMINATOR EXTRA STRENGTH PAIN RELIEF- caffeine, acetaminophen, aspirin capsule

  • NDC Code(s): 84269-2533-1, 84269-2533-2
  • Packager: Wildman Business Group
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 1, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 250 mg

    Aspirin (NSAID*) 250 mg

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    temporarily relieves minor aches and pains due to

    • headache
    • muscular aches
    • arthritis pain
    • a cold
    • toothache
    • 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 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: 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.

    Allergy alert: Aspirin (NSAIDs) 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 caplets 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:

    • are 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)
    • take more or for a longer time than directed
    • have 3 or more alcoholic drinks every day while using this product

    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

    Do not use

    • 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 ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers

    ASK DOCTOR

    Ask a doctor before use if

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

    ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for gout, diabetes, or arthritis
    • taking any other drug, or under a doctor's care for any serious condition

    STOP USE

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

    These could be signs of a serious condition.

    PREGNANCY OR BREAST FEEDING

    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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed
    • drink a full glass of water with each dose

    Adults and children: (12 years and over) Take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • read all product information before using. Keep box for important information.
    • store at room temperature 68º-77ºF (20º-25ºC)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
    • each caplet contains: Magnesium 0.58 mg
  • INACTIVE INGREDIENT

    Inactive ingredients

    colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyvinyl pyrrolidone, polyethylene glycol, pregelatinized starch, starch 1500, stearic acid, talc

  • QUESTIONS

    Questions or comments? (888) 602-0288

  • Principal Display Panel – 100 Caplet Box Label

    2533

    PAIN TERMINATOR

    Advanced Severe Pain Formula

    Pull to Open

    Fast Relief of:

    • Headaches
    • Muscle Aches
    • Back Aches
    • Arthritis Pain

    The Provision

    First Aid

    Line™

    BY WILDMAN

    100 Caplets

    2 Per Packet

    Principal Display Panel – 100 Caplet Box Label
  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR   EXTRA STRENGTH PAIN RELIEF
    caffeine, acetaminophen, aspirin capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84269-2533
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (white to off white with specks) Scoreno score
    ShapeCAPSULE (capsule shaped, biconvex) Size18mm
    FlavorImprint Code S53
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84269-2533-2100 in 1 BOX07/01/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:84269-2533-150 in 1 BOX07/01/2024
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/01/2024
    Labeler - Wildman Business Group (016677338)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals LTD.863182240MANUFACTURE(84269-2533)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794PACK(84269-2533)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761PACK(84269-2533)