Label: ACETAMINOPHEN solution

  • NDC Code(s): 0121-2094-00, 0121-2094-11
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2025

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  • Active ingredient (in each 10.15 mL)

    Acetaminophen 325 mg

  • Purposes

    Pain reliever/fever reducer

  • Uses

    • for the temporary relief of minor aches and pains due to

    • headache
    • muscular aches
    • backache
    • sore throat
    • flu
    • the common cold
    • toothache
    • premenstrual and menstrual cramps

    • for the minor pain from arthritis
    • and to reduce fever

  • Warnings

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

    • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 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.

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

  • ASK DOCTOR

    Ask a doctor before use if the user
       •  has liver disease
       •  is a child with pain of arthritis

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

  • Stop use and ask a doctor if

    • adult's pain gets worse or lasts more than 10 days
    • child's pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

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

  • Keep out of reach of children.

  • OVERDOSAGE

    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 for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see overdose warning)
    • dose product from the single dose cup the product is packaged in
    • mL=milliliter
    age dose
    adults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours
    not to exceed 6 doses in a 24-hour period
    children 6 to under 12 years of age10.15 mL (325 mg) every 4 hours
    not to exceed 5 doses in a 24-hour period
    children under 6 years of ageconsult a doctor
  • Other information

    ■ Each 10.15 mL contains: sodium 12 mg

    ■ store at 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

  • Questions or comments?

    Call 1-800-845-8210. You may also report serious side effects to this phone number.

  • Distributed by:

    PAI Pharma
    Greenville,SC 29605
    www.paipharma.com
    R05/25

  • PRINCIPAL DISPLAY PANEL - 10.15 mL Cup

    Delivers 10.15 mL

    NDC 0121-2094-11

    Acetaminophen
    Oral Solution USP
    325 mg/10.15 mL

    Pain Reliever/Fever Reducer

    Alcohol Free/Dye Free/Sugar Free
    Grape Flavored

    Package Not Child-Resistant

    Dist. by: PAI Pharma
    GREENVILLE, SC 29605
    See insert for drug facts

     

    lidding for 10.15 mL Acetaminophen Oral Soln FN1047

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-2094
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10.15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-2094-0010 in 1 CASE12/09/2025
    110 in 1 TRAY
    1NDC:0121-2094-1110.15 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 DrugM01312/09/2025
    Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-2094)
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