EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET [MECHANICAL SERVANTS LLC]

EXTRA STRENGTH HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET [MECHANICAL SERVANTS LLC]
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NDC 29485-0752-6
Set ID b3a06e4b-0b31-4e2a-8dd1-9de85760477b
Category HUMAN OTC DRUG LABEL
Packager Mechanical Servants LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)Purposes
    Acetaminophen 250 mgPain reliever/fever reducer
    Aspirin (NSAID)* 250 mgPain reliever/fever reducer
    Caffeine 65 mgPain reliever aid

    * nonsteroidal anti-inflammatory drug

  • Use

    temporarily relieves minor aches and pains due to:

    backache
    headaches
    colds
    muscular aches
    minor arthritis pain
    menstrual cramps
    Temporarily reduces fever.

  • 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 behaviour 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


    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 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen (perscription or nonperscription). If you are not sure wether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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, iritability, sleeplessness, and occasionally rapid heart beat.

    Do not use

    • if you are allergic to aspirin or any other pain reliever / fever reducer
    • with any other pain reliever/fever reducer
    • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
    • if you have ever had an allergic reaction to any other pain reliever-fever reducer
    • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

    Ask a doctor before using if:

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

    Ask a doctor or pharmacist before use if you are taking a prescription drug for

    • anticoagulation (thinning of blood)
    • diabetes
    • gout
    • arthritis

    When using this product do not exceed recommended dose.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if:

    • an allergic reaction occurs. Seek medical help right away.
    • ringing in the ears or loss of hearing occurs
    • pain or fever persists or gets worse
    • new symptoms occur
    • redness or swelling is present
    • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

    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 SPECIFICALLY 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(1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • adults and children 12 years of age and older:
      2 tablets as needed for pain every 6 hours.
      Do not exceed 8 tablets in 24 hours or as directed by a doctor.
    • children under 12 years: consult a doctor
  • Other information

    • TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN, CUT OR OPENED
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • avoid excessive heat and humidity
  • Inactive ingredients

    Hydroxypropyl Methylcellulose*, Maltodextrin*, Microcrystalline Cellulose, Polyethylene Glycol*, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid, Titanium Dioxide*

    *contains one or more of these ingredients

  • Questions or comments?

    1-844-428-2538

  • SPL UNCLASSIFIED SECTION

    Manufactured by Ultratab Laboratories, Inc

    Repackaged and distributed by
    Convenience Valet ®, Glendale Heights, IL 60139

  • PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Package

    Extra Strength

    Headache Relief

    Acetaminophen

    Aspirin (NSAID)

    and Caffeine

    Pain Reliever/Fever Reducer

    COMPARE TO THE ACTIVE INGREDIENTS IN

    EXCEDRIN® EXTRA STRENGTH

    6 TABLETS [tablet image]

    Headache PDP

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH HEADACHE RELIEF 
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-0752
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR9
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-0752-63 in 1 PACKAGE01/31/2013
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/31/2013
    Labeler - Mechanical Servants LLC (005530951)

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