PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION]

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  • PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION]

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [RITE AID CORPORATION]
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NDC 11822-0812-1, 11822-0812-2, 11822-0812-4, 11822-0812-5, 11822-0812-6, 11822-0812-8
Set ID d846065a-5c39-4f4b-894c-4280acaaf4fa
Category HUMAN OTC DRUG LABEL
Packager Rite Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART343
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  • 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 of 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 11822-0812-5

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

    EXTRA STRENGTH PAIN RELIEF
    ACETAMINOPHEN

    ACETAMINOPHEN 500 mg
    PAIN RELIEVER/FEVER REDUCER

    contains no aspirin

    ACTUAL SIZE

    50
    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      REV0617F17515

    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.

    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0812-31 in 1 CARTON04/02/1993
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-0812-51 in 1 CARTON04/02/1993
    250 in 1 BOTTLE, PLASTIC; 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:11822-0812-11 in 1 CARTON04/02/1993
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:11822-0812-21 in 1 CARTON04/02/1993
    512 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:11822-0812-81 in 1 CARTON04/02/1993
    624 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:11822-0812-4500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/02/1993
    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) , pack(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(11822-0812)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-0812)
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