Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen capsule, gelatin coated

  • NDC Code(s): 55315-519-12, 55315-519-15, 55315-519-57
  • Packager: FRED'S, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • Active ingredient (in each gelcap)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

    Liver warning:  This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 ever day while using this product

    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.

    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.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take mroe than directed
      (see overdose warning)
    • adults and children 12 years and over
      • take 2 gelcaps every 4 to 6 hours while symptoms last
      • do not take more than 8 gelcaps in 24 hours
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
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  • Inactive ingredients

    croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

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  • Product Packaging

    FRED'S®

    Extra Strength
    Pain Reliever
    Acetaminophen
    Pain Reliever/Fever Reducer
    Rapid Release Gel Caps

    50 Gelcaps, 500 mg each

    Compare to the active ingredient in:
    Extra Strength Tylenol®  Rapid Release Gels*

    *This product is not manufactured or distributed McNeil Consumer Healthcare, owner of the registered trademark Extra Strength® Rapid Release Gels.
    50844        REV0213D51915

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

    Fred's 44-519

    Fred's 44-519

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen capsule, gelatin coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-519
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 33  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    HYDROXYPROPYL CELLULOSE (TYPE H)  
    HYPROMELLOSES  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    PROPYLENE GLYCOL  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code L;5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-519-57 1 in 1 CARTON
    1 125 in 1 BOTTLE, PLASTIC
    2 NDC:55315-519-12 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    3 NDC:55315-519-15 1 in 1 CARTON
    3 50 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/10/2004
    Labeler - FRED'S, INC. (005866116)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55315-519)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55315-519)
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