Label: CHILDREN ACETAMINOPHEN ORAL SOLUTION- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 19, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (per 5 mL teaspoonful)

    Acetaminophen 160 mg

  • PURPOSE

    Purpose

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    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

    Warnings

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

    • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
    • child takes more than 5 doses 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 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.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed
    • find dose in chart below
    • if possible, use weight to dose, otherwise use age
    • dosage may be repeasted 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 Teaspoonful (tsp)  consult Physician 1 tsp (5 mL) 1 1/2 tsp (7.5 mL) 2 tsp (10 mL) 2 1/2 tsp (12.5 mL) 3 tsp (15 mL) 4 tsp (20 mL)

  • INACTIVE INGREDIENT

    Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CHILDREN ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-7014(NDC:0904-7014)
    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:17856-7014-172 in 1 BOX, UNIT-DOSE04/19/2024
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-7014-248 in 1 BOX, UNIT-DOSE04/19/2024
    25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:17856-7014-350 in 1 BOX, UNIT-DOSE04/19/2024
    315.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:17856-7014-4120 in 1 BOX, UNIT-DOSE04/19/2024
    42.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    5NDC:17856-7014-5120 in 1 BOX, UNIT-DOSE04/19/2024
    51.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    6NDC:17856-7014-6120 in 1 BOX, UNIT-DOSE04/19/2024
    62.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    7NDC:17856-7014-750 in 1 BOX, UNIT-DOSE04/19/2024
    720.31 mL in 1 CUP, UNIT-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    8NDC:17856-7014-850 in 1 BOX, UNIT-DOSE04/19/2024
    831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    9NDC:17856-7014-972 in 1 BOX, UNIT-DOSE04/19/2024
    910.15 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 DrugM10/01/2019
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-7014)
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