Label: CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER- acetaminophen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 25, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (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)
    tsp. = teaspoon
    mL = milliliter
    under 6 mos.ask a doctor
    6 mos. to under 22.5 mL or ½ tsp.
    2 to under 45 mL or 1 tsp.
    4 to under 67.5 mL or 1½ tsp.
    6 to under 910 mL or 2 tsp.
    9 to under 1112.5 mL or 2½ tsp.
    11 to under 1215 mL or 3 tsp.
    or as directed by a 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, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

  • 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 Suspension

    Pain Reliever / Fever Reducer

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

    Alcohol Free • Aspirin Free • Ibuprofen Free

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

    ROTATING
    LABEL FOR
    WEIGHT-BASED
    DOSING

    Strawberry
    Flavor

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

    NDC 45014-138-04

    Principal Display Panel - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACCUDIAL   PAIN RELIEVER/ FEVER REDUCER
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-138
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Strawberry (UNII: 4J2TY8Y81V)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Corn Syrup (UNII: 9G5L16BK6N)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Sorbitol (UNII: 506T60A25R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-138-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34304/25/2012
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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