Label: DRX CHOICE TENSION HEADACHE- acetaminophen, caffeine tablet, film coated

  • NDC Code(s): 68163-506-15
  • Packager: Raritan Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 13, 2025

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

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 65 mg

  • Purposes

    Pain reliever

    Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pain 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
    • 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 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

    • 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.

    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 at 1-800-222-1222. 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
    • children under 12 years: ask a doctor
  • Other information

    • store at room temperature
    • close cap tightly after use
    • read all product information before using.
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, D&C red no. 27, FD&C blue no. 2, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    Compare to Excedrin® Tension Headacheactive ingredients *

    NDC 68163-506-15

    DRx Choice

    tension headache

    relief

    ASPIRIN-FREE

    Acetaminophen 500 mg,Caffeine 65 mg

    Pain Reliever / Pain Reliever Aid

    ACTUAL SIZE

    15 CAPLETS

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING.

    IMPORTANT:Keep this carton for future reference on full labeling.

    Distributed by: Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick, NJ 08816

    *This product is not manufactured or distributed by Haleon CH Sarl., owner of the registered trademark Excedrin Tension Headache.

    DRx Choice Tension Headache  Relief 15 caplets
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE   TENSION HEADACHE
    acetaminophen, caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-506
    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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (Caplet) Size17mm
    FlavorImprint Code RP065
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-506-151 in 1 CARTON05/16/2025
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/16/2025
    Labeler - Raritan Pharmaceuticals Inc. (127602287)