Label: ACETAMINOPHEN tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 24, 2019

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  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen USP, 650 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

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

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

    •
    more than 6 caplets in 24 hours, which is the maximum daily amount
    •
    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:

    •
    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

    •
    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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 (see overdose warning)

    adults

    ▪ take 2 caplets every 8 hours with water
    ▪ swallow whole - do not crush, chew, split or dissolve
    ▪ do not take more than 6 caplets in 24 hours
    ▪ do not use for more than 10 days unless directed by a doctor

    under 18 years of age

    ▪ ask a doctor
  • OTHER INFORMATION

    •
    store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
    •
    see end panel for batch number and expiration date
    •
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • INACTIVE INGREDIENTS

    Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    fred's®

    Use only as directed.

    LAST UP TO 8 HOURS

    Arthritis Pain Relief

    Acetaminophen Extended-Release Tablets USP, 650 mg

    Pain Reliever/Fever Reducer

    For The Temporary Relief of Minor Arthritis Pain

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    50 CAPLETS* (*capsule-shaped tablets)

    Compare To Active Ingredient of Tylenol®Arthritis Pain†

    DISTRIBUTED BY: fred's, Inc.

    APAP-50caplets
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule Shaped) Size19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-333-5050 in 1 BOTTLE; Type 0: Not a Combination Product12/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620004/30/2004
    Labeler - Fred's Inc. (005866116)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(55315-333)
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