PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]

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PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [ACCUDIAL PHARMACEUTICAL, INC.]
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NDC 45014-131-04
Set ID 7eb3f185-6b4a-4674-8658-79132b1f6aec
Category HUMAN OTC DRUG LABEL
Packager Accudial Pharmaceutical, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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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.

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

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

    When using this product

    Do not exceed recommended dose.

    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). Quick medical attention is critical, even if you do not notice any signs or symptoms.

  • Directions

    • shake well before using
    • if needed, repeat dose every 4 hours
    • do not use more than 5 times in 24 hours
    • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
    • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
    Age (yr)Dose (mL or tsp)
    under 2 yearsask a doctor
    2-3 years5 mL or 1 tsp.
    4-5 years7.5 mL or 1½ tsp.
    6-8 years10 mL or 2 tsp.
    9-10 years12.5 mL or 2½ tsp.
    11 years15 mL or 3 tsp.
  • Other information

    • each teaspoon contains: sodium 2 mg
  • Storage & Package Safety

    • do not use if inner foil seal is broken or missing
    • store between 20°-25°C (68°-77°F)
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 120 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    ACCURATE DOSING BY WEIGHT

    CONTAINS
    Acetaminophen
    Oral Suspension

    Pain Reliever,
    Fever Reducer
    For Ages 2 to under 12

    Alcohol Free • Aspirin Free • Ibuprofen Free

    80 mg per 1/2 teaspoon
    (160 mg per 5 mL)

    CHERRY
    FLAVOR

    Compares to
    Children's
    Tylenol ®.

    4 FL.OZ.
    (120 mL)
    NDC 45014-131-04

    Principal Display Panel - 120 mL Carton
  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-131
    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
    Cherry (UNII: BUC5I9595W)  
    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
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-131-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34301/04/2010
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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