Label: ACETAMINOPHEN liquid

  • 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 1, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL teaspoonful)

    Acetaminophen, USP 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • arthritis
    • the common cold
    • toothache
    • menstrual cramps
    • reduces fever
  • Warnings

    Liver Warning

    This product contains acetaminophen.

    Severe liver damage may occur if you take:

    • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
    • 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.

    Ask a doctor before use

    if you have health issues especially liver disease.

    Ask a doctor or pharmacist before use

    if you are taking other drugs, including the blood thinner warfarin.

    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 in this product.

    Stop use and ask a doctor if

    • new symptoms occur such as rash, hives, itching or hoarseness
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • symptoms do not improve

    These could be signs of a serious condition.

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    Do not exceed recommended dosage.

    Overdose Warnings

    Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

    • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
    • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
  • Other information

    If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

  • Inactive ingredients

    Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate,Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

  • Questions?

    You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 or FDA at 1-800-FDA-1088.

  • HOW SUPPLIED

    Product: 50090-6059

    NDC: 50090-6059-0 118 mL in a BOTTLE, PLASTIC

  • ACETAMINOPHEN liquid

    Label Image
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6059(NDC:69367-323)
    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)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-6059-0118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34305/05/2021
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6059)