Label: ACETAMINOPHEN suspension

  • 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 April 11, 2023

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


    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses


    • 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

    • adult takes more than 4,000 mg of acetaminophen in 24 hours
    • 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 your child has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if your child has liver disease

    Ask a doctor or pharmacist before use if the user 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 10 days (for adults) or 5 days (for children)
    • 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

    • do not give this product to children for pain of arthritis unless directed by a doctor

    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

    • Use as directed per healthcare professional.
    • do not take more than directed (see overdose warning)
    • shake well before using
    • 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 as directed by a doctor
    under 24under 2 yearsask a doctor
    24-352-3 years5 mL
    36-474-5 years7.5 mL
    48-596-8 years10 mL
    60-719-10 years12.5 mL
    72-9511 years15 mL
    Over 96Adults and children 12 years and over20 mL
  • Other information

    • each 5 mL contains: sodium 3 mg
    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate


    Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

  • How Supplied

    NDC 68094-042-58
    2.5 mL per unit dose ENFit syringe
    Fifty (50) syringes per shipper

    NDC 68094-038-58
    5 mL per unit dose ENFit syringe
    Fifty (50) syringes per shipper

    NDC 68094-231-61
    5 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-231-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-330-61
    10.15 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-330-62
    10.15 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-030-62
    20.3 mL per unit dose cup
    Thirty (30) cups per shipper


    Distributed By
    Perrigo Company
    Allegan, MI 49010

    Packaged By
    Precision Dose, Inc.
    South Beloit, IL 61080

    For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email

    LI1593 Rev. 05/22

  • PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

    LSY1526 Rev. 02/22
    NDC 68094-038-01



    160 mg / 5 mL Delivers 5 mL

    Store at 20-25°C (68-77°F)

    Hospital Use Only • Alcohol Free
    Aspirin Free • Gluten Free • Ibuprofen Free

    For Oral Use Only

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-038(NDC:0113-0212)
    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)  
    butylparaben (UNII: 3QPI1U3FV8)  
    calcium sulfate, unspecified form (UNII: WAT0DDB505)  
    carrageenan (UNII: 5C69YCD2YJ)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    glycerin (UNII: PDC6A3C0OX)  
    high fructose corn syrup (UNII: XY6UN3QB6S)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sodium phosphate, tribasic (UNII: A752Q30A6X)  
    Product Characteristics
    ColorPURPLE (viscous) Score    
    FlavorGRAPEImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-038-585 in 1 CASE09/30/2022
    110 in 1 BAG
    1NDC:68094-038-015 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34309/30/2022
    Labeler - Precision Dose, Inc. (035886746)
    NameAddressID/FEIBusiness Operations
    Precision Dose, Inc.035886746REPACK(68094-038)