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 June 7, 2017

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

  • Drug Facts

    Tension Headache Relief

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  • Purpose

    Pain reliever, Pain reliever aid

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  • Active Ingredients (in each caplet)

    Acetaminophen   500mg

    Caffeine   65mg

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  • Uses

    Temporarily relief minor aches and pains due to:

    • Headache
    • Muscular aches
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  • 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.

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  • 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.
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  • Ask a doctor before use

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

    If you are taking the blood thinning drug warfarin.

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  • 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
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  • If pregnant or breast-feeding

    Ask a health professional before use.

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  • 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.

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  • 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
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  • Other Information

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

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

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  • Tension Headache Relief Acetaminophen 500mg Caffeine 65mg 24 CapletsCompare to Excedrin® Tension Headache active ingredients Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com
  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF 
    acetaminophen 500mg tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-118
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color red Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69517-118-24 1 in 1 CARTON 05/31/2017
    1 24 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    Name Address ID/FEI Business Operations
    Healthlife of USA 079656178 repack(69517-118)
    Establishment
    Name Address ID/FEI Business Operations
    Elysium Pharmaceuticals Limited 915664486 manufacture(69517-118) , pack(69517-118)
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