Label: PAIN RELIEF REGULAR STRENGTH- acetaminophen tablet

  • NDC Code(s): 11822-0104-1, 11822-0104-7
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 1, 2023

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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    Liver warning: This product contains acetaminophen. 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
    • 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 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
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days in children under 12 years
    • new symptoms occur
    • 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    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
    • do not take for more than 10 days unless directed by a doctor 
    children 6-11 years
    • take 1 tablet every 4 to 6 hours while symptoms last
    • do not take more than 5 tablets in 24 hours
    • do not take for more than 5 days unless directed by a doctor
    children under 6 years        ask a doctor

  • Other information

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

    corn starch, povidone, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    NDC 11822-0104-1

    Compare to the active ingredient of Regular Strength Tylenol®*

    REGULAR STRENGTH
    PAIN RELIEF
    ACETAMINOPHEN

    ACETAMINOPHEN 325 mg

    PAIN RELIEVER/FEVER REDUCER

    RITE
    AID®
    PHARMACY

    ACTUAL SIZE

    100 TABLETS

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered 
    trademark Regular Strength Tylenol®.
    50844     REV0417D10412

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE,
    CAMP HILL, PA  17011
    www.riteaid.com

    SATISFACTION
    GUARANTEE
    If you're not satisfied, we'll
    happily refund your money.

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

     

    Rite Aid 44-104

    Rite Aid 44-104

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  REGULAR STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code 44;104
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0104-11 in 1 CARTON07/13/1990
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11822-0104-71 in 1 CARTON07/13/199009/06/2021
    2125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/13/1990
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-0104)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(11822-0104)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-0104)
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