BACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]

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BACTIMICINA CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [DLC LABORATORIES, INC.]
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NDC 24286-1550-4
Set ID bdade270-d813-4178-b594-4951632b6839
Category HUMAN OTC DRUG LABEL
Packager DLC Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL = 1 teaspoonful)

    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

    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 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 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 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.

  • 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 the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • 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)*
    *
    or as directed by a doctor
    Under 24Under 2 yearsAsk a doctor
    24-352-3 years5 mL (1 tsp)
    36-474-5 years7.5 mL (1½ tsp)
    48-596-8 years10 mL (2 tsp)
    60-719-10 years12.5 mL (2½ tsp)
    72-9511 years15 mL (3 tsp)

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

  • Other information

    • each teaspoon (5 mL) contains: sodium 2 mg
    • store at room temperature
    • dosage cup provided
    • do not use if printed bottle wrap is missing or broken
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxypropyl methycellulose, purified water, sodium benzoate, sorbitol, xanthan gum

  • Questions

    1-800-858-3889

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    DLC Laboratories, Inc.
    Paramount, CA 90723 USA

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    LIQUID
    BACTIMICINA®

    Acetaminophen
    Pain Reliever - Fever Reducer


    Children's
    Pain &
    Fever

    Ages 2-11

    Relieves:

    • FEVER
    • HEADACHE
    • MINOR ACHES & PAIN

    See new warnings information

    Alcohol Free
    Aspirin Free

    Cherry Flavor

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BACTIMICINA CHILDRENS PAIN AND FEVER 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1550
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1550-41 in 1 BOX11/17/2014
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/17/2014
    Labeler - DLC Laboratories, Inc. (093351930)
    Establishment
    NameAddressID/FEIBusiness Operations
    DLC Laboratories, Inc.093351930MANUFACTURE(24286-1550) , LABEL(24286-1550)
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