GOOD SENSE PAIN RELIEFCHILDRENS CHILDRENS (ACETAMINOPHEN) SUSPENSION [AIDAREX PHARMACEUTICALS LLC]

GOOD SENSE PAIN RELIEFCHILDRENS CHILDRENS (ACETAMINOPHEN) SUSPENSION [AIDAREX PHARMACEUTICALS LLC]
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NDC 33261-770-01
Set ID 45ddd71d-de6c-4e21-a22a-0b37afcc429b
Category HUMAN OTC DRUG LABEL
Packager Aidarex Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each 5 mL = 1 teaspoon)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • •reduces fever
    • •relieves minor aches and pains due to:
    • •the common cold
    • •flu
    • •headache
    • •sore throat
    • •toothache
  • 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 has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if your child has

    liver disease

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dose (see overdose warning)

    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 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

    • •this product does not contain directions or complete warnings for adult use
    • •do not give more than directed (see overdose warning)
    • •shake well before using
    • •mL = milliliter; tsp = teaspoonful
    • •find right dose on chart. If possible, use weight to dose; otherwise, use age.
    • •remove the children protective cap and squeeze your child’s dose into the dosing cup
    • •repeat dose every 4 hours while symptoms last
    • •do not give more than 5 times in 24 hours
     

    Weight (lb)

     

    Age (yr)

     

    Dose (mL or tsp)*

     

    under 24

     

    under 2 years

     

    ask a doctor

     

    24-35

     

    2-3 years

     

    5 mL (1 tsp)

     

    36-47

     

    4-5 years

     

    7.5 mL ( 1 ½ tsp)

     

    48-59

     

    6-8 years

     

    10 mL (2 tsp)

     

    60-71

     

    9-10 years

     

    12.5 mL (2 ½ tsp)

     

    72-95

     

    11 years

     

    15 mL (3 tsp)

    *or as directed by a doctor

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • •each 5 mL (1 tsp) contains: sodium 3 mg
    • •store at 20-25°C (68-77°F)
    • •do not use if printed neckband is broken or missing
  • Inactive ingredients

    anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    For Ages 2 – 11

    Children’s

    Pain Relief

    Acetaminophen Oral Suspension

    Fever Reducer/Pain Reliever

    Suspension Liquid

    Alcohol Free

    Aspirin Free

    Ibuprofen Free

    Grape Flavor

    Compare to active ingredient of Children’s Tylenol® Oral Suspension

    160 mg per 5 mL

    IMAGE LABEL

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

  • INGREDIENTS AND APPEARANCE
    GOOD SENSE PAIN RELIEFCHILDRENS  CHILDRENS
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-770(NDC:0113-0130)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    Product Characteristics
    ColorPURPLE (viscous) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33261-770-011 in 1 CARTON
    1118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/25/1993
    Labeler - Aidarex Pharmaceuticals LLC (801503249)

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