Label: TENSION HEADACHE RELIEF ASPIRIN FREE- acetaminophen, caffeine tablet, film coated

  • NDC Code(s): 50844-428-08
  • Packager: L.N.K. International, Inc.
  • 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 August 21, 2019

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

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Caffeine 65 mg

  • Purpose

    Pain reliever
    Pain reliever aid

  • Uses

    • 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 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 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

    • new symptoms appear
    • symptoms do not get better or worsen
    • painful area is red and swollen
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts 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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 (see overdose warning)
    • adults and children 12 years and over: take 2 caplets every 6 hours.  Do not take more than 8 caplets in 24 hours.
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

  • Questions or comments?

     1-800-426-9391

  • Principal display panel

    QUALITY PLUS

    NDC 50844-428-08 

    *Compare to the active ingredients in Excedrin® Tension Headache

    Aspirin Free

    Tension Headache Relief
    Acetaminophen
    & Caffeine
    Pain Reliever/Pain Reliever Aid

    24 Coated Caplets

    Actual Size

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® Tension Headache.

    50844    REV0113A42808

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Quality Plus 44-428

    Quality Plus 44-428

  • INGREDIENTS AND APPEARANCE
    TENSION HEADACHE RELIEF  ASPIRIN FREE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-428
    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
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;428
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-428-081 in 1 CARTON01/17/2007
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/17/2007
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(50844-428)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(50844-428)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(50844-428)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(50844-428)