Label: ACETAMINOPHEN solution

  • NDC Code(s): 81033-002-05, 81033-002-10, 81033-002-20, 81033-002-30, view more
    81033-002-31, 81033-002-40, 81033-002-41, 81033-002-50, 81033-002-51
  • Packager: Kesin Pharma Corporation
  • Category: HUMAN OTC DRUG LABEL
  • 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 July 1, 2021

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

  • DRUG FACTS

  • Active Ingredients (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 more than 5 doses in in 24 hours, which is the maximum daily amount for this product
    • child takes more than 5 doses in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has more alcoholic drinks everyday 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: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years or age unless directed by physician.

    Do not use

    Ask a doctor before use

    Ask a doctor before use if the user has liver disease.

    Ask a doctor or pharmacist before use

    Do no 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.

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

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

    Stop use and ask a doctor if

    Stop use and ask a doctor if

    • symptoms do not improve
    • pain gets worse or lasts more than 5 days
    • 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.

    Keep out of reach of children.

    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

    • do not take more than directed (see overdose warning)
    • do not take more than 5 doses in any 24-hour period
    • dose as follows or as directed by doctor:
    • take only with dosing cup provided
    • adults and children 12 years of age and older: 20 mL (640 mg) in dosing cup every 6 hours
    • children under 12 years of age: ask a doctor
    • this product does not contain directions or complete warnings for use
  • OTHER INFORMATION

    each 5 mL contains: sodium 8 mg

    store at 20 -25°C (68 -77°F)

    tamper evident: DO NOT use if foil on cup is missing or torn

    Alcohol Free, Dye Free, Sugar Free

  • INACTIVE INGREDIENTS

    Citric acid, grape flavor[Ma1] , edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

    grape flavor

  • QUESTIONS OR COMMENTS?

    Call 1-833-537-4679

  • PRINCIPAL DISPLAY PANEL

    5mL container label

    10.15mL container label

    20.3mL container label

    NDC 81033-002-05

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers160mg/5mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by

    Kesin Pharma Phoenix, AZ

    Alcohol, Dye, Sugar Free

    NDC 81033-002-10

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers 325mg/10.15mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by

    Kesin Pharma Phoenix, AZ

    Alcohol, Dye, Sugar Free

    NDC 81033-002-20

    Acetaminophen Oral Solution

    160mg/5mL

    Delivers 650mg/20.15mL

    Store at 68° - 77° F

    LOT

    EXP

    PKG by

    Kesin Pharma Phoenix, AZ

    Alcohol, Dye, Sugar Free

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-002
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-002-418 in 1 CASE06/30/2021
    1NDC:81033-002-4040 in 1 CARTON
    1NDC:81033-002-1010.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:81033-002-518 in 1 CASE06/30/2021
    2NDC:81033-002-5050 in 1 CARTON
    2NDC:81033-002-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:81033-002-318 in 1 CASE06/30/2021
    3NDC:81033-002-3030 in 1 CARTON
    3NDC: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 not finalpart34306/30/2021
    Labeler - Kesin Pharma Corporation (117447816)