Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet

  • NDC Code(s): 72090-004-02
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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

  • Active Ingredients  (in each caplet)

    Acetaminophen 500mg
    Caffeine 65 mg

  • Purpose

    Acetaminophen 500mg............................................................................................................Pain reliever
    Caffeine 65mg................................................................................................................... Pain reliever aid

  • Uses:

    temporarily relieves minor aches and pains due to:

    •headache
    •muscular aches

  • Warnings:

    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 6 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

    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 heartbeat.

    Do not use

    •if you are allergic to acetaminophen
    •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 Doctor:

    Ask a doctor before use if

    •you have liver disease

  • ASK DOCTOR/PHARMACIST:

    Ask a doctor or pharmacist before use if you are

    •taking the blood thinning drug warfarin

  • Stop use and ask doctor if 

    ■any new symptoms occur

    ■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. These could be signs of a serious condition.

  • PREGNANCY

    If pregnant or breast-feeding, ask a health professional before use.

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

  • DIRECTIONS

    Do not use more than directed

    ■adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours

    ■chlidren under 12 years: ask a doctor

  • OTHER INFORMATION

    •store at 20°-25°C (68°-77°F)

    •close cap tightly after use
    •read all product information before using.

  • INACTIVE INGREDIENTS

    Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9AM to 5PM EST.

  • PRINCIPAL DISPLAY PANEL

    Tension Headache Relief

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (Capsule shape Tablet) Size28mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-004-02200 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/03/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)