Label: TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet

  • NDC Code(s): 68210-4108-1, 68210-4108-2, 68210-4108-5
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredients (in each caplet)Purposes
     Acetaminophen 500 mg Pain reliever
     Caffeine 65 mg Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
  • WARNINGS

    Warnings

    Liver Warning: This product contains acataminophen. Severe liver damage may occure if you take.

    • more than 6 caplets in 24 hours, whihc is the maximum daily amount.
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    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, 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 a doctor before use if you have

    • liver disease

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • any new symptoms occur
    • painful area is red or swollen
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts for more than 3 days

    These could be signs of a serious condition

    If pregnant or breast feeding,

    ask a health professional before use.

    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. 1-800-222-1222

  • 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
    • children 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. Keep this box for important information.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, FD&C Blue#2, FD&C Yellow#6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Tension Headache Relief

    • Acetaminophen & Caffeine

    Pain Reliever/ Pain reliever aid

    Actual Size

    image

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4108
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (CAPSULE SHAPED TABLET) Size18mm
    FlavorImprint Code S431
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4108-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
    2NDC:68210-4108-2200 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
    3NDC:68210-4108-5150 in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/05/2020
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)
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