Label: ACETAMINOPHEN 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 12, 2020

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

    do not take more than directed (see overdose warning)
    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 4 to under 6 years of age

    7.5 mL (240 mg) every 4 hours
    not to exceed 5 doses in a 24-hour period

    children 2 to under 4 years of age

    5 mL (160 mg) every 4 hours
    not to exceed 5 doses in a 24-hour period

    children under 2 years of age

    consult 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:

    Available:

    650 mg/20.3 mL

    Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

  • 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

    Distributed by:
    Cardinal Health

    Dublin, OH 43017

    L53336120218

    R07/19

  • Principal Display Panel

    Acetaminophen Oral Solution USP

    650 mg/20.3 mL

    5 Cups

    bag label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9449(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, 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:55154-9449-55 in 1 BAG08/01/2007
    120.3 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 - Cardinal Health (603638201)