Label: ACETAMINOPHEN SOLUTION- acetaminophen liquid

  • NDC Code(s): 39328-031-05, 39328-031-50, 39328-031-99, 39328-032-10, view more
    39328-032-50, 39328-032-99, 39328-034-20, 39328-034-50, 39328-034-99
  • Packager: Patrin Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 21, 2024

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

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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 relieves minor aches and pains due to:

    • headache
    • muscular 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:

    • an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
    • a child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • taken with 3 or more alcoholic drinks every day while using this product

    Allergy

    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

    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
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • if you are allergic to acetaminophen or any of the inactive ingredients of his 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

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present

    If pregnant or breastfeeding, 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 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)
    • Use the following dosage guidelines when using this product
    AGEDOSE
    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 4 to under 6 years of age7.5 mL (240 mg) every 4 hours
    Not to exceed 5 doses in a 24-hour period
    Children 2 to under 4 years of age5 mL (160 mg) every 4 hours
    Not to exceed 5 doses in a 24-hour period
    Children under 2 years of ageConsult a doctor
  • Other Information

    • Each 5 mL contains: sodium 2 mg
    • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • Keep tightly closed
    • Protect from light
    • Do not use if foil on cup is missing or torn
  • Inactive Ingredients

    Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sorbitol.

  • Questions Or Comments?

    Call (800) 936-3088. You may also report serious side effects to this phone number.

  • How Supplied

    • A red, cherry flavored solution supplied in the following oral dosage cups:
    NDC 39328-031-05:5 mL unit dose cup
    NDC 39328-031-50:Case contains 50 unit dose cups of 5 mL (39328-031-05).
    NDC 39328-031-99:Case contains 100 unit dose cups of 5 mL (39328-031-05).
    NDC 39328-032-10:10.15 mL unit dose cup
    NDC 39328-032-50:Case contains 50 unit dose cups of 10.15 mL (39328-032-10).
    NDC 39328-032-99:Case contains 100 unit dose cups of 10.15 mL (39328-032-10).
    NDC 39328-034-20:20.3 mL unit dose cup
    NDC 39328-034-50:Case contains 50 unit dose cups of 20.3 mL (39328-034-20).
    NDC 39328-034-99:Case contains 100 unit dose cups of 20.3 mL (39328-034-20).
  • SPL UNCLASSIFIED SECTION

    Patrin Pharma
    Skokie, IL 60076
    www.patrinpharma.com

    Rev 02.0424

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    Delivers 5 mL
    NDC 39328-031-05
    Acetaminophen
    Oral Solution USP
    160 mg/5 mL
    Alcohol Free
    For Institutional Use Only
    See Insert

    Lot# xxxxxx
    Exp: yyyy/mm/dd
    Patrin Pharma
    Skokie, IL 60076
    Rev 03.0324

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

    Delivers 10.15 mL
    NDC 39328-032-10
    Acetaminophen
    Oral Solution USP
    325 mg/10.15 mL
    Alcohol Free
    For Institutional Use Only
    See Insert

    Lot# xxxxxx
    Exp: yyyy/mm/dd
    Patrin Pharma
    Skokie, IL 60076
    Rev 03.0324

    PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label

    Delivers 20.3 mL
    NDC 39328-034-20
    Acetaminophen
    Oral Solution USP
    650 mg/20.3 mL
    Alcohol Free
    For Institutional Use Only
    See Insert

    Lot# xxxxxx
    Exp: yyyy/mm/dd
    Patrin Pharma
    Skokie, IL 60076
    Rev 03.0324

    PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN SOLUTION 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-031
    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 RED NO. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    Saccharin sodium (UNII: SB8ZUX40TY)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39328-031-505 in 1 CASE09/27/2023
    110 in 1 TRAY
    1NDC:39328-031-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:39328-031-9910 in 1 CASE05/13/2024
    210 in 1 TRAY
    2NDC:39328-031-055 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 drugM01309/27/2023
    ACETAMINOPHEN SOLUTION 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-032
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    Saccharin sodium (UNII: SB8ZUX40TY)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39328-032-505 in 1 CASE09/27/2023
    110 in 1 TRAY
    1NDC:39328-032-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:39328-032-9910 in 1 CASE05/13/2024
    210 in 1 TRAY
    2NDC:39328-032-1010.15 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 drugM01309/27/2023
    ACETAMINOPHEN SOLUTION 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-034
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    Saccharin sodium (UNII: SB8ZUX40TY)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39328-034-505 in 1 CASE10/16/2023
    110 in 1 TRAY
    1NDC:39328-034-2020.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:39328-034-9910 in 1 CASE05/13/2024
    210 in 1 TRAY
    2NDC:39328-034-2020.3 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 drugM01310/16/2023
    Labeler - Patrin Pharma, Inc. (806841677)
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