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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/14

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

  • ACTIVE INGREDIENT

    Active Ingredient
    (In each 5 mL)
    Acetaminophen 160 mg

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  • PURPOSE

    Purpose
    Pain reliever/Fever reducer

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  • INDICATIONS & USAGE

    Uses temporarily:

    • Reduces fever
    • Relieves minor aches and pains due to:
    • Common Cold
    • Headache
    • Sore throat
    • Toothache
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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.

    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.


    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) Prompt 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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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • DOSAGE & ADMINISTRATION

    Directions:

    • This product does not contain directions or complete warnings for adult use.
    • Shake well before using
    • Find the correct dose on the chart below; if possible, use weight to dose. Otherwise use age
    • Use only the enclosed dispenser for use with this product
    • If needed, repeat dose every 4 hours
    • Do not give more than 5 times in 24 hours
    • Do not give more than 2 days unless directed by a doctor

    Do not give more than directed (see overdose warning)

    Weight (lb) Age (yr) Dose Children’s TEMPRA Syrup (mL)

    34-24 lb 2-3 years 5 mL

    35-46 lb 4-5 years 7.5 mL

    47-59 lb 6-8 years 10 mL

    60-71 lb 9-10 years 12.5 mL

    72-95 lb 11 years 15 mL

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  • STORAGE AND HANDLING

    Other Information

    • store below 30 C (86 F)
    • do not use if the cap seal is torn or broken
    • see top panel for lot number and expiration date.
    • product color may very 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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  • INGREDIENTS AND APPEARANCE
    TEMPRA 
    acetaminophen syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64613-5800
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYANISOLE  
    CITRIC ACID MONOHYDRATE  
    D&C RED NO. 33  
    POLYETHYLENE GLYCOL 1450  
    WATER  
    SODIUM CHLORIDE  
    SODIUM CITRATE  
    STRAWBERRY  
    SUCROSE  
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 05/10/2011
    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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