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Acetaminophen (Accudial Pharmaceutical, Inc.)

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LIQUID 120 mL in 1 BOTTLE (45014-130-04) Label Information

Complete Acetaminophen Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient Purpose (in each 5 mL = 1 teaspoon)

    Acetaminophen 160 mg


  • Purpose

    Pain reliever/fever reducer


  • Uses

    Temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

    Temporarily reduces fever


  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount.
    • with other drugs containing acetaminophen.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if your child has liver disease.

    Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

    When using this product

    Do not use more than directed.

    Stop use and ask a doctor if
    • Pain gets worse or lasts more than 5 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.

    Keep out of reach of children.

    Overdose warning

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


  • Directions

    This product does not contain directions or complete warnings for adult use.

    • shake well before using
    • if needed, repeat dose every 4 hours
    • do not use more than 5 times in 24 hours
    • when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
      when weight is unknown: use the age chart on the rotating label.
    • use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
    Age (yr) Dose (mL or tsp)
    under 6 mos. ask a doctor
    6 mos. to under 2 2.5 mL or ½ tsp.
    2 to under 4 5 mL or 1 tsp.
    4 to under 6 7.5 mL or 1½ tsp.
    6 to under 9 10 mL or 2 tsp.
    9 to under 11 12.5 mL or 2½ tsp.
    11 to under 12 15 mL or 3 tsp.
    or as directed by a doctor
    tsp. = teaspoon mL = milliliter

  • ASK DOCTOR

    Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.


  • Other information

    • each teaspoon contains: sodium 2 mg
    • store between 20°-25°C (68°-77°F)
    • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

  • Inactive ingredients

    artificial flavor, citric acid anhydrous USP, D&C Red #33, FD&C Red #40, glycerin USP, non-crystalline sorbitol 70% USP, polyethylene glycol NF, propylene glycol, purified water, sodium benzoate, sodium saccharin.


  • Questions?

    877-434-2036


  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
    Palm Beach Gardens, FL 33408


  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    Children's
    ACCUDIAL®

    Acetaminophen
    Oral Solution

    Pain Reliever / Fever Reducer

    For ages 6 mos. to
    under 12 or 12-95 lbs.

    Alcohol Free Aspirin Free Ibuprofen Free

    Compares to the active
    ingredient in Children's
    Tylenol® Oral Solution.

    ROTATING
    LABEL FOR
    WEIGHT-BASED
    DOSING

    Cherry Flavor

    4 FL. OZ. (120 mL)
    80 mg per 1/2 teaspoon
    (160 mg per 5 mL)

    NDC 45014-130-04

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-130
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Anhydrous citric acid (UNII: XF417D3PSL)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Water (UNII: 059QF0KO0R)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Prunus Serotina Bark (UNII: 5D48E975HA)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45014-130-04 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 10/01/2011
    Labeler - Accudial Pharmaceutical, Inc. (831999201)