Label: ACETAMINOPHEN solution

  • NDC Code(s): 60687-751-42, 60687-751-48, 60687-751-56
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2024

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

  • Purpose

    Pain reliever/fever reducer

  • Active ingredient (in each 10.15 mL cup)

    Acetaminophen     325 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 10 unit dose cups in 24 hours, which is the maximum daily amount
    • child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
    • 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.
    • 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 thinning 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 over

    20.3 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 age

    10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period

    children under 6 years of age

    consult a doctor

  • Other information

    • Each 10.15 mL contains: sodium 4 mg
    • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • protect from light
    • a red, cherry flavored solution supplied in the following oral dosage forms:
      10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56
  • 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.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF SEAL IS BROKEN.

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    R03/23

  • Principal Display Panel – Tray Label

    Tray Label

    Case NDC 60687-751-56/Cup NDC 60687-751-42

    ACETAMINOPHEN
    ORAL SOLUTION USP

    325 mg/10.15 mL

    ALCOHOL FREE

    Each 10.15 mL contains:
    Acetaminophen      325 mg

    USUAL DOSAGE: See attached Drug Facts

    Store at 20° to 25°C (68° to 77°F)
    [See USP Controlled Room Temperature].

    For Institutional Use Only.

    T0657C110323              R03/23

  • Principal Display Panel – Cup – 325 mg / 10.15 mL

    325 mg/10.15 mL Acetaminophen Oral Solution Cup

    NDC 60687- 751-42

    ACETAMINOPHEN
    ORAL SOLUTION USP

    Pain Reliever/Fever Reducer

    325 mg/10.15 mL

    ALCOHOL FREE

    Delivers 10.15 mL

    Protect from light.

    See packaging Drug Facts insert for full
    prescribing information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0657C110323

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-751
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-751-5610 in 1 CASE07/28/2023
    1NDC:60687-751-4810 in 1 TRAY
    1NDC:60687-751-4210.15 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 DrugM01307/28/2023
    Labeler - American Health Packaging (929561009)