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 June 8, 2020

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  • Active Ingredient

    Active ingredient (in each 5 mL cup) ‑ Purpose Acetaminophen USP 160 mg…………………………..………………..Pain reliever / fever reducer

  • Purpose

    Pain reliever / fever reducer

  • Acetaminophen 160 mg / 5 mL Unit Dose Cup

    Directions

    Do not use more than directed Shake well before use

    Age (yr)

    Dose (mL)

    adults
    •
    take 20 mL (640 mg) every 4 to 6 hours
    •
    not to exceed 6 doses in a 24-hour period
    •
    do not use more than 10 days unless directed by a doctor

    under 18 years of age
    •
    ask a doctor
  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Warnings and Precautions

    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

    Warnings

    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.

  • Do Not Use

    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

    - 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 of a serious condition

    Inactive Ingredients

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

    Indications and Usage

    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
  • Generic Section

    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

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L55967620320

  • Principal Display Panel

    Acetaminophen Oral Solution, USP

    160 mg/ 5 mL

    5 Cups

    bag label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen oral solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-8088(NDC:0904-6738)
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8)  
    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:55154-8088-55 in 1 BAG04/08/2019
    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 finalpart34304/08/2019
    Labeler - Cardinal Health (603638201)
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