Label: ACETAMINOPHEN- acetaminophen tablet 

  • NDC Code(s): 57344-003-01, 57344-003-02, 57344-003-03, 57344-003-04, view more
    57344-003-05, 57344-003-06, 57344-003-07, 57344-003-11, 57344-003-99
  • Packager: AAA Pharmaceutical, 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 12/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • Uses

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

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (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 every 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.
    • 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.

    Close
  • Directions

    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 use for more than 10 days unless directed by a doctor
    children under 12 years
    • ask a doctor
    Close
  • Other information

    • store between 20-25°C (68-77°F)
    • retain carton for complete product information
    Close
  • Inactive ingredients

    povidone, pregelatinized starch, sodium starch glycolate, stearic acid

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048

    Close
  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

    RESTORE u

    NDC 57344-003-02

    COMPARE TO THE ACTIVE
    INGREDIENT IN TYLENOL®
    EXTRA STRENGTH

    EXTRA
    STRENGTH
    CONTAINS NO ASPIRIN

    Pain Relief
    Pain Reliever, Fever Reducer

    Contains Acetaminophen

    60 TABLETS - 500 mg each

    PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-003
    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
    POVIDONES  
    STARCH, CORN  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code M2A4;57344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-003-01 1 in 1 CARTON
    1 30 in 1 BOTTLE, PLASTIC
    2 NDC:57344-003-02 1 in 1 CARTON
    2 60 in 1 BOTTLE, PLASTIC
    3 NDC:57344-003-03 100 in 1 BOTTLE, PLASTIC
    4 NDC:57344-003-04 1 in 1 CARTON
    4 100 in 1 BOTTLE, PLASTIC
    5 NDC:57344-003-05 1000 in 1 BOTTLE, PLASTIC
    6 NDC:57344-003-06 100 in 1 BOTTLE, PLASTIC
    7 NDC:57344-003-07 500 in 1 BOTTLE, PLASTIC
    8 NDC:57344-003-11 1000 in 1 BOTTLE, PLASTIC
    9 NDC:57344-003-99 39604 in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/13/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 181192162 MANUFACTURE(57344-003)
    Establishment
    Name Address ID/FEI Business Operations
    AAA Pharmaceutical, Inc. 010411533 PACK(57344-003)
    Close