PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FRED'S, INC.]

  • Home
  • PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FRED'S, INC.]

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FRED'S, INC.]
PDF | XML
NDC 55315-135-12
Set ID 0c23c9e6-2054-4ef4-9abc-b8d7ffeecdc8
Category HUMAN OTC DRUG LABEL
Packager FRED'S, INC.
Generic Name
Product Class
Product Number
Application Number PART343
View All Sections
  • Active ingredient (in each tablet)

    Acetaminophen 500 mg 

  • Purpose

    Pain reliever/fever reducer 

  • Uses

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

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product 

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    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

    • pain gets worse or lasts more than 10 days
    • 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 6 hours while symptoms last
      • do not take more than 6 tablets 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

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

    corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

    *may contain this ingredient

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    fred's
    Pharmacy

    NDC 55315-135-12

    Compare to the active ingredient in:
    Extra Strength Tylenol®†

    ACTUAL
    SIZE

    Extra Strength
    Pain Reliever

    Acetaminophen
    Pain Reliever/Fever Reducer

    100 Tablets, 500 mg each

    Easy to Swallow

    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®.
    50844         ORG101853112

    DISTRIBUTED BY: fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com

    100% satisfaction guaranteed
    Questions or comments: 1-855-331-FRED (3733)

    Freds 44-531C

    Freds 44-531C

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    TALC (UNII: 7SEV7J4R1U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;531
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-135-121 in 1 CARTON12/11/200504/08/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/11/200504/08/2022
    Labeler - FRED'S, INC. (005866116)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55315-135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(55315-135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55315-135)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(55315-135)
View All Sections

Related Drugs

Search DailyMed Drugs