Label: DRX CHOICE REGULAR STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 68163-065-60
  • Packager: Raritan Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 3, 2025

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • muscular aches
      • backache
      • minor pain of arthritis
      • the common cold
      • toothache
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    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.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if the user

    • hasliver disease
    • is a child with pain of arthritis

    Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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

    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

    adults and children 12 years and over

    • take 2 tablets every 4 to 6 hours while symptoms last
    • do not take more than 10 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    children 6 years to under 12 years

    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not use for more than 5 days unless directed by a doctor

    children under 6 years

    ask a doctor

  • Other information

    • store at room temperature.
  • Inactive ingredients

    hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide

  • Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    DRx Choice®

    Compare to the active ingredient in Tylenol® Regular Strength*

    NDC 68163-065-60
    regular strength

    pain relief

    Acetaminophen 325 mg

    Pain Reliever / Fever Reducer
    60 tablets

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

    *This product is not manufactured or distributed by Kenvue Inc, owner of the registered trademark Tylenol® Regular Strength

    Distributed by: Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick, NJ 08816


    DRx Choice regular Strength Pain Relief 60 Tablets
  • INGREDIENTS AND APPEARANCE
    DRX CHOICE   REGULAR STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-065
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-065-6060 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/16/2025
    Labeler - Raritan Pharmaceuticals Inc. (127602287)