Label: FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT- acetaminophen 160mg per 5ml solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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  • Active Ingredient (in each 5mL)

    Acetaminophen, 160mg

  • 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 for this product

    ■ with other drugs containing acetaminophen.

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    ■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away

    Sore throat warning: if sore throat is severe, persistent 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 your child

    has liver disease

    Ask a doctor or pharmacist before use if your

    child is taking the blood thinning drug warfarin

    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.

    In case of accidental 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

    ■ do not give more than directed (see overdose warning)

    ■ use the chart below to confirm dose. If possible, use weight to dose, otherwise, use age.

    ■ give the recommended number of vials below. To open, follow the instructions under How to Use.

    ■ if needed, repeat dose every 4 hours while symptoms last.

    ■ do not give more than 5 times in 24 hours

    ■ do not give for more than 5 days unless directed by a doctor

    Weight (lbs)Age (Years)Dose
    under 24 lbs.under 2 yearsAsk a doctor
    24-35 lbs.2 - 3 years

    1 Single Use Vial (5 mL)
    36-47 lbs.4-5 yearsAsk a doctor
    48-71 lbs.6-10 Years

    2 Single Use Vial (10 mL)
    72-95 lbs11 years3 Single Use Vial (15 mL)

  • Other Information

    ■ Each Single Use Vial contains 8mg of sodium

    ■ Store at 68-77°F (20-25°C)

    ■ Tamper Evident: do not use if the pouch is damaged, open or broken. Do not use if any vial is open or broken.

  • Inactive Ingredient

    citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum.

  • Questions or Comments?

    1-833-WTF-FRIDA (1-833-983-3743)

  • Package

    PDPDrug Facts Label

  • INGREDIENTS AND APPEARANCE
    FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT 
    acetaminophen 160mg per 5ml solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-124
    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
    MALTITOL (UNII: D65DG142WK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72705-124-1010 in 1 POUCH08/16/2022
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/16/202208/31/2024
    Labeler - Fridababy LLC (783729598)
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