Label: TEMPERAL-ITO- acetaminophen suspension

  • NDC Code(s): 69729-006-02, 69729-006-04
  • Packager: OPMX Chula Vista
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2024

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  • Active Ingredient(in each 5 mL) Purpose - 118 mL

    Acetaminophen 160 mg............. Pain reliever/fever reducer

  • PURPOSE

    Pain Reliever & Fever Reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
    • sore throat
    • the common cold
    • flu
    • headache
    • toothache
  • Warnings -118 mL

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if your child takes 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 (prescnption or non-prescription). 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 or pharmacist before use if your child is taking the blood thinning drug warfarin.

    When using this product do not exceed recommened dose (see overdose warning)

  • STOP USE

    Stop use and ask a doctor if

    • new sympthoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions - 118 mL

    • this product does not contain directions or complete warnings for adult use. Shake well before using
    • mL= millilitar
    • find right dose on chart below, if possible, use weight to dose; otherwise, use age
    • repeat dose every 4 hours while symptoms last
    • only use enclosed measuring syringe
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor
    *

    Weight (Ib)

    Age (yr)

    Dose (mL) *

    under 24

    under 2

    ask a doctor

    24-35

    2-3

    5 mL

    36-47

    4-5

    7.5 mL

    48-59

    6-8

    10 mL

    60-71

    9-10

    12.5 mL

    72-95

    11

    15 mL

  • Other information

    • Each teaspoon (5 mL) contains: sodium 3 mg
    • Store between 15°-30°C (59°-86°F)
    • Protect from freezing. Protect from light

  • Inactive ingredients

    acesulfame potassium, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

  • Questions or comments?

    Call toll free 619-600-5632

    Monday through Fnday 9AM - 5PM EST

  • Active Ingredient(In each 5 mL) Purpose - 60 mL

    Acetaminophen 160 mg..............Pain reliever/fever reducer

  • Purpose

    Pain Reliever & Fever Reducer

  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
    • the common cold
    • headache
    • flu
    • sore throat
    • toothache
  • Warnings - 60 mL

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

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

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

    • skin reddening
    • blister
    • rash

    if a skin reaction occurs, stop use and seek medical help right away.


    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 (prescnption or non-prescription). 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 or pharmacist before use if your child is taking the blood thinning drug warfarin.

    When using this product do not exceed recommened dose (see overdose warning)

  • STOP USE

    Stop use and ask a doctor if

    • new sympthoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children

  • OVERDOSAGE

    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions - 60 ml

    • 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
    • find right dose on chart below, if posible, use weight to dose; otherwise, use age
    • only use enclosed measuring syringe
    • repeat dose ebery 4 hours while symptoms last
    • do not give more than 5 times in 24 hours

    Weight (lb)Age (yr)Dose (mL) *
    under 24under 2 yearsask a doctor
    24-352-3 years5 mL

    *or as directed by doctor

  • Other Information

    • store between 20°-25°C (68°-77°F)
    • protect from freezing
    • protect from light

  • Inactive Ingredients

    acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

  • Questions or comments?

    Call toll free 619-600-5632
    Monday through Fnday 9AM - 5PM EST

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-006-04 Temperal-ito

    Children Fever Temperalito 4 floz

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-006-02

    Temperal-ito Infant Fever 2 floz

  • INGREDIENTS AND APPEARANCE
    TEMPERAL-ITO 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-006
    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
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-006-041 in 1 CARTON06/02/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69729-006-021 in 1 CARTON06/02/2023
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01306/02/2023
    Labeler - OPMX Chula Vista (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seaway Pharma117218785manufacture(69729-006)
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