Label: ACETAMINOPHEN suspension

  • NDC Code(s): 0121-0941-00, 0121-0941-05, 0121-0941-94, 0121-1882-00, view more
    0121-1882-11, 0121-1882-94, 0121-2823-21, 0121-2823-94
  • Packager: PAI Holdings, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    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

    • 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 you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if the user 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 the 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 take 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: 2 mg
    • Store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.

  • SPL UNCLASSIFIED SECTION

    Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

  • How Supplied

    • grape flavored suspension supplied in the following oral dosage forms:

    NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups.

    NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups.

    NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.

  • QUESTIONS

    Call 1-800-845-8210.

  • MANUFACTURED BY

    Pharmaceutical Associates, Inc.

    Greenville, SC 29860

    www.paipharma.com

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC 0121-0941-05

    ACETAMINOPHEN ORAL SUSPENSION

    160 mg per 5 mL

    DYE FREE/GRAPE FLAVOR

    Ibuprofen Free/Alcohol Free/Aspirin Free

    Pain Reliever-Fever Reducer

    SHAKE WELL BEFORE USING

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label

    NDC 0121-1882-11

    ACETAMINOPHEN ORAL SUSPENSION

    325 mg per 10.15 mL

    DYE FREE/GRAPE FLAVOR

    Ibuprofen Free/Alcohol Free/Aspirin Free

    Pain Reliever-Fever Reducer

    SHAKE WELL BEFORE USING

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label

    NDC 0121-2823-21

    ACETAMINOPHEN ORAL SUSPENSION

    650 mg per 20.3 mL

    DYE FREE/GRAPE FLAVOR

    Ibuprofen Free/Alcohol Free/Aspirin Free

    Pain Reliever-Fever Reducer

    SHAKE WELL BEFORE USING

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0941
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (to Off-white) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0941-943 in 1 CASE09/03/2021
    110 in 1 TRAY
    1NDC:0121-0941-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-0941-0010 in 1 CASE09/03/2021
    210 in 1 TRAY
    2NDC:0121-0941-055 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 DrugM01309/03/2021
    ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1882
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (to Off-white) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1882-943 in 1 CASE09/03/2021
    110 in 1 TRAY
    1NDC:0121-1882-1110.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:0121-1882-0010 in 1 CASE09/03/2021
    210 in 1 TRAY
    2NDC:0121-1882-1110.15 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 DrugM01309/03/2021
    ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-2823
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20.3 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorwhite (to Off-white) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-2823-943 in 1 CASE09/03/2021
    110 in 1 TRAY
    1NDC:0121-2823-2120.3 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 DrugM01309/03/2021
    Labeler - PAI Holdings, LLC (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693label(0121-0941, 0121-1882, 0121-2823) , manufacture(0121-0941, 0121-1882, 0121-2823)
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