Label: ACETAMINOPHEN solution

  • NDC Code(s): 66689-055-01, 66689-055-99
  • Packager: VistaPharm, LLC
  • 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 December 19, 2022

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  • Active ingredient (in each 10.15 mL)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ■ temporarily relieves minor aches and pains due to:

    ■ headache

    ■ muscle aches

    ■ backache

    ■ minor pain of arthritis

    ■ the common cold

    ■ toothache

    ■ premenstrual and menstrual cramps

    ■ temporarily reduces fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    ■ more than 4000 mg in 24 hours

    ■ with other drugs containing acetaminophen

    ■ 3 or more alcoholic drinks every day while using this product

    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.

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have liver disease

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    ■ pain gets worse or lasts more than 10 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.

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

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    ■ do not take more than directed (see overdose warning)

    ■ do not take more than 8 doses in any 24-hour period

    ■ dose as follows or as directed by doctor

    ■ take only with dosing cup provided

    ■ adults and children 12 years of age and older: 10.15 mL (325 mg) every 3 - 4 hours

    ■ children under 12 years of age: ask a doctor

  • Other information

    ■ each 10.15 mL contains: sodium 16 mg

    ■ store at 20 -25°C (68 -77°F)

    ■ do not use if foil on cup is missing or torn

  • Inactive ingredients

    anhydrous citric acid, FD&C blue no. 1, FD& C red no. 40, flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin

  • Questions or comments?

    Call 1-888-655-1505

  • How Supplied

    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.

    Distributed by:

    VistaPharm Inc.

    Largo, FL 33771, USA

    VP2511

    10/2019

  • Principal Display Panel - 10.15 mL Lidding Label

    ACETAMINOPHEN Oral Solution, USP     

    325 mg per 10.15 mL

    [160 mg/5 mL]

    Alcohol-Free

    Delivers 325 mg [10.15 mL]

    Store at 20°-25°C (68°-77°F); [see USP CRT conditions]. 

    Distributed by:

    VistaPharm, Inc.

    Largo, FL 33771, USA

    NDC 66689-055-01

    VP2155R2

    02/18

    lidding-label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66689-055
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66689-055-9910 in 1 CASE11/22/201909/30/2023
    110 in 1 TRAY
    1NDC:66689-055-0110.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/22/201909/30/2023
    Labeler - VistaPharm, LLC (116743084)
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