Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, film coated

  • NDC Code(s): 11822-0812-1, 11822-0812-2, 11822-0812-3, 11822-0812-4, view more
    11822-0812-5, 11822-0812-6, 11822-0812-8
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 14, 2023

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

View All Sections
  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • with other drugs containing acetaminophen
    • more than 4,000 mg of acetaminophen in 24 hours
    • 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 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

    • redness or swelling is present
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur

    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 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets in 24 hours, unless directed by a doctor
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

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

    castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    NDC 11822-0812-2

    Compare to the active ingredient in
    Extra Strength Tylenol® Caplets*

    EXTRA STRENGTH PAIN RELIEF
    ACETAMINOPHEN

    ACETAMINOPHEN 500 mg
    PAIN RELIEVER/FEVER REDUCER

    contains no aspirin

    ACTUAL SIZE

    12
    CAPLETS

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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the
    registered trademark Extra Strength Tylenol® Caplets.             
    50844 REV0621G17502

    DISTRIBUTED BY:
    RITE AID, 200 NEWBERRY COMMONS
    ETTERS, PA 17319 www.riteaid.com

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

    Rite Aid 44-175

    Rite Aid 44-175

    .

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0812-21 in 1 CARTON04/02/1993
    112 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11822-0812-31 in 1 CARTON04/02/199307/11/2021
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11822-0812-61 in 1 CARTON04/02/199310/08/2021
    316 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:11822-0812-81 in 1 CARTON04/02/199309/23/2024
    424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:11822-0812-4500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/199310/21/2024
    6NDC:11822-0812-51 in 1 CARTON04/02/199311/17/2024
    650 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:11822-0812-11 in 1 CARTON04/02/199301/26/2025
    7100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/02/1993
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088manufacture(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117597853pack(11822-0812)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!