Label: ACETAMINOPHEN solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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  • ACETAMINOPHEN Oral Solution 160mg per 5mL

    ACETAMINOPHEN Oral Solution
    160mg per 5mL

  • Active Ingredients (in each 5 mL)

    Acetaminophen 160 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    Temporarily relieves minor aches and pains due to:

    • headaches
    • backaches
    • toothaches
    • muscular aches
    • minor pain of arthritis
    • the common cold
    • premenstrual and menstrual cramps
    • sore throat
    • flu

    Temporarily reduces fever

  • WARNINGS

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

    • adult takes more than more than 6 doses in 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 everyday while using this product

    Ask a doctor before use if the user has liver disease.
    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, persistent for more than 2 days, or is accompanied or followed by a fever,
    headache, nausea, rash, or vomiting, consult a physician 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 3 days for fever unless directed by a doctor

    • for more that 10 days for pain unless directed by a doctor

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

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

    Stop use and ask a doctor if

    Stop use and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present

    These could be signs of a serious condition.

    If Pregnant or breast-feedinging

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

    Keep out of reach of children.

    KEEP OUT OF REACH OF CHILDREN.

    Overdose warning:

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

  • DIRECTIONS

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

    Age

    Dose
    adults and children 12 years of age and over20.3 mL (650 mg) every 4 to 6 hours not to excdeed 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 under 2 years of ageconsult a doctor

  • OTHER INFORMATION

    • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
    • keep tightly closed
    • protect from light
    • tamper evident: DO NOT use if foil on cup is missing or torn
    • a clear, grape flavored solution supplied in the following oral dosage forms:

    NDC 81033-002-05: 5 mL (160mg) unit dose cup
    NDC 81033-002-55: Case contains 100 unit dose cups of 5 mL (81033-002-05); packaged in a carton of 50 unit dose cups each.
    NDC 81033-002-10: 10.15mL (325mg) unit dose cup
    NDC 81033-002-54: Case contains 100 unit dose cups of 10.15 mL (81033-002-10); packaged in a carton of 50 unit dose cups
    each.
    NDC 81033-002-20: 20.3 mL (650mg) unit dose cup
    NDC 81033-002-53: Case contains 100 unit dose cups of 20.3 mL (81033-002-20); packaged in a carton of 50 unit dose cups
    each.

  • INACTIVE INGREDIENTS

    Citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

  • QUESTIONS OR COMMENTS?

    Call Kesin Pharma at 1-833-537-4679. You may also report serious side effects to this phone number.

    Packaged by:
    Kesin Pharma
    Oldsmar, FL 34677
    Effective: 08/2024

    Revision 01

    Kesin Pharma Logo

  • PRINCIPAL DISPLAY PANEL

    NDC 81033-002-05

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers160mg/5mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by Kesin Pharma

    Oldsmar, FL

    Alcohol, Dye, Sugar Free

    For Institutional Use

    5mL container label

    NDC 81033-002-10

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers 325mg/10.15mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by Kesin Pharma

    Oldsmar, FL

    Alcohol, Dye, Sugar Free

    For Institutional Use

    10.15mL container label

    NDC 81033-002-20

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers 650mg/20.15mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by Kesin Pharma

    Oldsmar, FL

    Alcohol, Dye, Sugar Free

    For Institutional Use

    20.3mL container label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-002(NDC:84447-104)
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-002-4040 in 1 CARTON06/30/2021
    1NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:81033-002-5050 in 1 CARTON06/30/2021
    2NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:81033-002-3030 in 1 CARTON06/30/2021
    3NDC:81033-002-2020.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:81033-002-55100 in 1 CASE06/30/2021
    4NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    5NDC:81033-002-54100 in 1 CASE06/30/2021
    5NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:81033-002-53100 in 1 CARTON06/30/2021
    6NDC:81033-002-2020.3 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 DrugM01306/30/2021
    Labeler - Kesin Pharma Corporation (117447816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma Corporation117447816repack(81033-002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma Corporation119132647repack(81033-002)
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