Label: TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 20, 2024

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

    •no 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 have ever had an allergic reaction 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 OR BREAST FEEDING

    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 (718) 337-8733 or visit support@nuvicare.com

  • PRINCIPAL DISPLAY PANEL

    PL0216-01 NC-Tension Headache Relief-100ct.jpg

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-002
    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:84324-002-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/30/2024
    Labeler - NUVICARE LLC (119257565)
    Registrant - NUVICARE LLC (119257565)