Label: REGULAR STRENGTH PAIN RELIEF- acetaminophen capsule, gelatin coated

  • NDC Code(s): 68210-0120-1
  • Packager: SPIRIT PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 8, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    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 softgels (3,250 mg) in 24 hours for adults or 5 softgels (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
    • do not give this product to children for the pain of arthritis unless directed by a doctor

    Ask a doctor before use if the user has liver disease

    Ask a doctor or pharmacist before use if the user is taking 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. (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 softgels every 4 to 6 hours while symptoms last
    • do not take more than 10 softgels in 24 hours
    • do not use for more than 10 days unless directed by a doctor
    children 6-11 years
    • take 1 softgel every 4 to 6 hours while symptoms last
    • do not take more than 5 softgels in 24 hours
    • do not use for more than 5 days unless directed by a doctor
    children under 6 yearsask a doctor

  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    Call 1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    SPIRIT PHARMACEUTICALS LLC.

    RONKONKOMA, NY 11779

  • PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton

    VALUMEDS

    COMPARE to the active ingredient in
     REGULAR STRENGTH TYLENOL®*

    REGULAR STRENGTH

    PAIN RELIEF

    Acetaminophen 325 mg

    PAIN RELIEVER/FEVER REDUCER

    10 softgels

    Actual Size

    APAP
  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH PAIN RELIEF 
    acetaminophen capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (OBLONG) Size21mm
    FlavorImprint Code 800
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0120-11 in 1 CARTON04/10/2018
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/10/2018
    Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)