Label: ACETAMINOPHEN ORAL SOLUTION solution

  • 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 March 21, 2022

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

  • Active ingredient

    Acetaminophen USP 325 mg

  • Purpose

    Pain reliever/ fever reducer

  • 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 Poison Control Center (1-800-222-

    1222) right away. Quick medical attention is critical for adults as well as for children even if you

    do not notice any signs or symptoms.

  • Uses

    temporarily relieves minor aches and pains due to:

    minor pain of arthritis
    muscular aches
    backache
    premenstrual and menstrual cramps
    the common cold
    headache
    toothache
    temporarily reduces fever
  • Warnings

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

    adults take more than 6 doses in 24 hours which is the maximum daily amount
    taken 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

  • 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.

    If you are allergic to acetaminophen or any other inactive ingredients in this product.

  • Ask Doctor

    Ask a doctor before use if this user

    Has liver disease
    Is pregnant or breast-feeding
  • Ask Doctor/Pharmacist

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop Use

    Stop use and ask a doctor if

    Pain gets worse or lasts more than 10 days
    new symptoms occur
    fever gets worse or lasts more than 3 days
    redness or swelling is present

    These could be signs or a serious condition

  • Directions

    Do not use more than directed
    Shake well before use

    Age (yr)

    Dose (mL)

    Adults

    take 20.3 mL (650 mg) every 4 to 6 hours
    not to exceed 6 doses in a 24-hour period
    do not take more than 10 days unless directed by doctor

    Under 18 years of age

    ask a doctor
  • Other Information

    store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
    protect from excessive moisture
    do not use if lid seal is open or damaged
    sugar free, dye free, alcohol free
    see bottom of cup for lot number and expiration date
  • Inactive Ingredients

    cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitrol, sucralose, xantham gum

    Questions

    Questions or comments?

    Call 1-800-616-2471

    Rev. 01/19

    Generic Section

    Distributed By:

    MAJOR® PHARMACEUTICALS

    Livonia, MI 48152

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L57472581221

  • Package/Label Principal Display Panel

    Acetaminophen Oral Solution, USP

    325 mg/10.15 mL

    5 Cups

    bag label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen oral solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3553(NDC:0904-6739)
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITE (white to light pink) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-3553-55 in 1 BAG12/04/2018
    110.15 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 finalpart34312/04/2018
    Labeler - Cardinal Health (603638201)