Label: ACETAMINOPHEN- acetaminophen solution

  • NDC Code(s): 66689-054-01, 66689-054-99, 66689-055-01, 66689-055-99, view more
    66689-056-01, 66689-056-99
  • Packager: VistaPharm, Inc.
  • 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 22, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Acetaminophen...........................160 mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Uses

    temporarily:

    • reduces fever
    • relieves minor aches and pains due to:
      • the common cold
      • immunizations
      • flu
      • sore throat
      • headache
      • toothache
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  • 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 of 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

    • symptoms do not improve
    • new symptoms 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.

    If pregnant or breast-feeding, ask a health professional before use.

    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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not give more than directed (see OVERDOSE WARNING).
    • mL = milliliter; tsp = teaspoon
    • find 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 (1lbs.)                          Age (yrs.)                       Dose (tsp or mL)*        
    under 24 under 2 ask a doctor
    24-35 2-3 years 1 tsp or 5 mL
    36-47 4-5 years 1 1/2 tsp or 7.5 mL
    48-59 6-8 years 2 tsp or 10 mL
    60-71  9-10 years 2 1/2 tsp or 12.5 mL
    72-95 11 years 3 tsp or 15 mL

    * or as directed by a doctor

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  • Other information

    • Store at controlled room temperature 20° - 25°C (68° to 77°F); excursions are permitted to 15° - 30°C (59° to 86°F). [See USP Controlled Room Temperature]
    • Protect from Freezing.
    • Protect from Light.
      Each teaspoon (5 mL) contains: sodium 7 mg
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  • Inactive ingredients

    citric acid, FD&C Red #40, flavor, glycerin, polyethylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

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  • Questions or comments?

    Call 1-888-655-1505 (toll-free)

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  • How Supplied

    Acetaminophen Oral Solution USP, 160 mg per 5 mL is a red solution supplied as follows:

    NDC 66689-054-01: 5 mL unit-dose cup

    NDC 66689-054-99: Case contains 100 unit-dose cups of 5 mL (NDC 66689-054-01), packaged in 10 trays of 10 unit-dose cups each.

    NDC 66689-055-01: 10.15 mL unit-dose cup

    NDC 66689-055-99: Case contains 100 unit-dose cups of 10.15 mL (NDC 66689-055-01), packaged in 10 trays of 10 unit-dose cups each.

    NDC 66689-056-01: 20.3 mL unit-dose cup

    NDC 66689-056-99: Case contains 100 unit-dose cups of 20.3 mL (NDC 66689-056-01), packaged in 10 trays of 10 unit-dose cups each.

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  • Distributed By:

    VistaPharm, Inc. logo

    VistaPharm, Inc.

    Largo, FL 33771, USA

    VP2158R1

    07/17

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  • PRINCIPAL DISPLAY PANEL - 20 mL Cup

    ACETAMINOPHEN Oral Solution, USP     

    650 mg/20.3 mL (160 mg/5 mL)

    Alcohol-Free

    Delivers 650 mg [20.3 mL]

    VistaPharm, Inc.
    Largo, FL 33771 USA

    NDC 66689-056-01

    VP2156R2

    02/18

    Acetaminophen Oral Solution 650 mg per 20.3 mL

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  • PRINCIPAL DISPLAY PANEL - 10 mL Cup

    ACETAMINOPHEN Oral Solution, USP     

    325 mg/10.15 mL (160 mg/5 mL)

    Alcohol-Free

    Delivers 325 mg [10.15 mL]

    VistaPharm, Inc.
    Largo, FL 33771 USA

    NDC 66689-055-01

    VP2155R2

    02/18

    Acetaminophen Oral Solution 325 mg per 10.15 mL
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  • PRINCIPAL DISPLAY PANEL - 5 mL Cup

    ACETAMINOPHEN Oral Solution, USP     

    160 mg/5 mL

    Alcohol-Free

    Delivers 160 mg [5 mL]

    VistaPharm, Inc.
    Largo, FL 33771 USA

    NDC 66689-054-01

    VP2154R2

    02/18

    Acetaminophen Oral Solution 160 mg per 5 mL

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-054
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-054-99 10 in 1 CASE 05/23/2018
    1 10 in 1 TRAY
    1 NDC:66689-054-01 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/23/2018
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-055
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-055-99 10 in 1 CASE 05/23/2018
    1 10 in 1 TRAY
    1 NDC:66689-055-01 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/23/2018
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-056
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM MONOHYDRATE (UNII: A9CO00M9HV)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-056-99 10 in 1 CASE 05/23/2018
    1 10 in 1 TRAY
    1 NDC:66689-056-01 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/23/2018
    Labeler - VistaPharm, Inc. (116743084)
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