Label: TENSION HEADACHE RELIEF capsule, coated

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

Drug Label Information

Updated November 22, 2021

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

View All Sections
  • Active ingredient(s)

    Acetaminophen 500 mg
    Caffeine 65mg

  • Purpose

    Pain reliever
    Pain reliever aid


  • Use(s)

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
  • Warnings

    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   ■ take with other drugs containing acetaminophen   ■ have 3 or more alcoholic drinks every day while using this product

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:   ■ hives   ■ facial swelling   ■ asthma (wheezing)   ■ shock
    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, 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 non-prescription). 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 for more than 10 days
    • fever gets worse or lasts for more than 3 days

    These could be signs of a serious condition.

    Pregnancy/Breastfeeding

    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.

  • Directions

    Do not use more than directed

    Adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

    Children under 12 years: ask a doctor

  • Other information

    • Store at 20-25°C (68-77° F) 
    • Do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40
    aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone,
    pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Questions


    1-888-952-0050 (Monday through Friday 9AM - 5PM EST

  • Principal Display Panel

    Tension Headache

    Tension Headache

    Tension Headache

    Tension Headache


  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    tension headache relief capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-001
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ029
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-001-241 in 1 CARTON11/22/2021
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/22/2021
    Labeler - Allegiant Health (079501930)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!