Label: EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet

  • NDC Code(s): 29485-0752-6
  • Packager: Mechanical Servants 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 March 25, 2019

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

  • 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

    Headache Relief Extra Strength BlisterHeadache Relief Extra Strength BlisterHeadache Relief Extra Strength Faceplate

    Headache Relief Extra Strength Blister
    Headache Relief Extra Strength Faceplate
    Headache Relief Extra Strength Faceplate
    Headache Relief Extra Strength Blister
    Headache Relief Extra Strength Faceplate
    Headache Relief Extra Strength Faceplate
    Headache Relief Extra Strength Blister
  • 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)