Label: TEMPRA- acetaminophen syrup

  • NDC Code(s): 64613-5800-2
  • Packager: Bristol-Myers Squibb de Mexico, S. de R.L. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 27, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Acetaminophen 160 mg/5 mL

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  • PURPOSE

    Purpose
    Pain reliever/Fever reducer

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  • INDICATIONS & USAGE

    Uses

    · temporarily relieves minor aches and pains due to:

    · the common cold

    · flu

    · headache

    · sore throat

    · toothache

    ·reduces fever

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • WARNINGS

    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.

    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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomit, 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 or pharmacist before use if the 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • DOSAGE & ADMINISTRATION

    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

    ·find the correct dose on the chart below. if possible, use weight to dose; otherwise use age.

    ·if needed, repeat dose every 4 hours

    ·do not give more than 5 times in 24 hours.

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24 lbs

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    5 mL

    36-47 lbs

    4-5 years

    7.5 mL

    48-59 lbs

    6-8 years

    10 mL

    60-71 lbs

    9-10 years

    12.5 mL

    72-95 lbs

    11 years

    15mL

    *or as directed by your doctor

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

    Other Information

    · each 5 mL contains: sodium 4 mg

    · store below 30ºC (86ºF)

    ·avoid high humidity

    · tamper evident: do not use if cap seal is torn or broken

    · product color may vary slightly over time from pink violet to wine red.

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Butylated Hydroxyanisole, Citric Acid, D&C Red No. 33, Polyethylene Glycol, Purified Water, Sodium Chloride, Sodium Citrate, Strawberry and other flavors, Sucrose.

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  • PRINCIPAL DISPLAY PANEL

    Questions or Comments? call 1-800-721-5072. You may also report side effects to this phone number.

    Keep carton for full directions for use.

    Manufactured by Bristol-Myers Squibb de Mexico, S de R.L. de C.V. Calzada de Tlalpan No. 2996, Col. Ejido Santa Ursula Coapa, 04870 Mexico D.F.

    MADE IN MEXICO.

    Tamper evident: do not use if cap seal is torn or broken.

    Lot

    Expiration Date

    Bristol-Myers Squibb

    Package Label

    1307449A3 jul2015 (2).jpg

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  • INGREDIENTS AND APPEARANCE
    TEMPRA 
    acetaminophen syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64613-5800
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY (Strawberry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64613-5800-2 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/10/2011 10/31/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/10/2011 10/31/2017
    Labeler - Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. (823646211)
    Establishment
    Name Address ID/FEI Business Operations
    Bristol-Myers Squibb de Mexico, S. de R.L. de C.V. 823646211 manufacture(64613-5800)
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