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 December 28, 2022

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  • Active Ingredient (per 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Purpose

    Pain Reliever / Fever Reducer

  • 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:

    • more than 5 doses is taken in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks everyday 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.
  • Ask a doctor before use if you have

    a liver disease.

  • Ask a doctor before use if you are

    taking the blood thinning drug warfarin.

  • When using this product: Do not exceed recommended dose.

  • Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children under 12 years
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present. 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. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

  • Directions:

    • Do not take more than directed
    • Find dose in chart below
    • If possible, use weight to dose, otherwise use age
    • Dosage may be repeated every 4 hours, or as directed by a doctor
    • Do not give more than 5 doses in 24 hours
     Weight (lbs)Under 24 24-35 36-4748-59  60-71 72-95 over 95
    Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult
    Dosage mL (tsp) Consult Physician5 mL (1 tsp )7.5 mL (1 1/2 tsp)10 mL (2 tsp)12.5 mL (2 1/2 tsp)15 mL (3 tsp)20 mL (4 tsp)
  • Other Information:

    • Store at room temperature 15°C- 30°C (59°F-86°F)
    • Protect from freezing
    • Protect from light
    • Aspirin Free
    • Alcohol Free
    • TAMPER-EVIDENT: Do not use if foil seal over syringe blister is torn, broken, or missing or if endcap is broken, missing, or separated from syringe.
    • For more info call 1-800-447-1006
  • Inactive Ingredients:

    Artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

  • SPL UNCLASSIFIED SECTION

    NDC: 48433-401-05 Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL)
    NDC: 48433-401-25 Box of 25 Unit-Dose Oral ENFit® Syringes, each unit-dose syringe delivers 5 mL

    For Oral Use Only.
    For Institutional Use Only.
    This Package Is Not Child Resistant.

    Mfd. in the U.S.A.
    Distributed by: Safecor Health, LLC
    4060 Business Park Drive, Columbus, OH 43204                                                  Rev: 07/2022 PN5727

  • Principal Display Panel

    SAFECOR HEALTH

    NDC 48433-401-05

    Acetominophen Oral Liquid

    160 mg / 5 mL

    (Delivers 5 mL)

    image description
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-401(NDC:54859-809)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-401-2525 in 1 BOX11/01/2022
    1NDC:48433-401-055 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2022
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287repack(48433-401) , relabel(48433-401)
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