Label: TENSION HEADACHE RELIEF- acetaminophen 500mg tablet, coated

  • 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 May 31, 2021

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  • Drug Facts

    Tension Headache Relief

  • Purpose

    Pain reliever, Pain reliever aid

  • Active Ingredients (in each caplet)

    Acetaminophen   500mg

    Caffeine   65mg

  • Uses

    Temporarily relief 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 6 tablets 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 

    • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • Ask a doctor before use

    • if you have liver disease
  • Ask a doctor or pharmacist

    If you are taking the blood thinning drug warfarin.

  • Stop use and ask a doctor if

    • Any new symptoms appear
    • Symptoms do not get better or worsen
    • 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
  • If pregnant or breast-feeding

    Ask a health professional before use.

  • Keep out of reach of children.

    In case of overdosage, 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 exceed recommended dosage.
    • Adults and children 12 years and over: Take 2 tablets every 6 hours; do not take more than 6 tablets in 24 hours
    • Children under 12 years: Ask a doctor
  • Other Information

    • Store at controlled room temperature 20°-25°C (68°-77°F)
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP 
  • Inactive Ingredients

    • Colloidal silicon doixide
    • Croscarmellose sodium
    • D&C red # 27
    • FD&C blue # 1
    • FD&C yellow # 6
    • Magnesium stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Pregelatinized starch
    • Polyvinyl pyrolidone
    • Stearic acid
    • Talc
    • Titanium dioxide
  • Questions or comments?

    Call toll free 1-844-384-3723 Monday through Friday 9AM - 5PM EST or www.safrel.com

  • Tension Headache Relief Acetaminophen 500mg Caffeine 65mg Compare to Excedrin® Tension Headache active ingredients Distributed by: Safrel Pharmaceuticals, LLC Bridgewater, NJ 08807 www.safrle.com

    TH

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen 500mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-105
    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. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-105-02200 in 1 BOTTLE03/01/2021
    1NDC:71309-105-241 in 1 CARTON
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/01/2021
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)
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