Label: ACETAMINOPHEN solution

  • NDC Code(s): 0121-0657-00, 0121-0657-05, 0121-1314-00, 0121-1314-11, view more
    0121-1971-00, 0121-1971-21
  • Packager: Pharmaceutical Associates, Inc.
  • 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 September 16, 2021

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

  • Purpose

    Pain reliever/fever reducer

  • Active ingredient (in each 5 mL teaspoonful)

    ACETAMINOPHEN 160 mg

  • 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 you take:

    • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses in 24 hours
    • with other drugs containing acetaminophen
    • 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.
    • 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 this product

    Ask a doctor before use if you have

    • liver disease

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

    Stop use and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse

    If pregnant or breast-feeding, 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

    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

    ■ a red, cherry flavored solution supplied in the following oral dosage forms:

    NDC 0121-0657-05:  5 mL unit dose cup

    NDC 0121-1314-11:  10.15 mL unit dose cup

    NDC 0121-1971-21:  20.3 mL unit dose cup

  • Inactive ingredients:

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

  • Questions or comments?

    Call 1-800-845-8210. You may also report serious side effects to this phone number.

  • MANUFACTURED BY:

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    www.paipharma.com

    R10/20

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup

    Delivers 5 mL

    NDC 0121-0657-05

    A cetaminophen O ral S olution USP

    160 mg/5 mL

    ALCOHOL FREE

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    F0657051020

    20 mL Unit Dose Cup Label

  • PRINCIPAL DISPLAY PANEL - 10 mL Cup

    Delivers 10.15 mL

    NDC 0121-1314-11

    A cetaminophen O ral S olution USP

    325 mg/10.15 mL

    ALCOHOL FREE

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    F06571110220

    10 mL Unit Dose Cup Label

  • PRINCIPAL DISPLAY PANEL - 20.3 mL Cup

    Delivers 20.3 mL

    NDC 0121-1971-21

    A cetaminophen O ral S olution USP

    650 mg/20.3 mL

    ALCOHOL FREE

    Package Not Child-Resistant

    PHARMACEUTICAL ASSOCIATES, INC.
    GREENVILLE, SC 29605

    SEE INSERT

    F0657211020

    20.3 mL Unit Dose Cup Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0657
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0657-0010 in 1 CASE08/01/2007
    110 in 1 TRAY
    1NDC:0121-0657-055 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 not finalpart34308/01/2007
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1314
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1314-0010 in 1 CASE08/01/2007
    110 in 1 TRAY
    1NDC:0121-1314-1110.15 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 not finalpart34308/01/2007
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1971
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1971-0010 in 1 CASE08/01/2007
    110 in 1 TRAY
    1NDC:0121-1971-2120.3 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 not finalpart34308/01/2007
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0657, 0121-1314, 0121-1971)