Label: CHILDREN ACETAMINOPHEN ORAL SOLUTION- 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 March 20, 2020

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

  • 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-DOSE02/05/2020
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-7014-248 in 1 BOX, UNIT-DOSE02/05/2020
    25 mL in 1 SYRINGE; Type 0: Not a Combination Product
    3NDC:17856-7014-350 in 1 BOX, UNIT-DOSE02/05/2020
    315.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:17856-7014-4120 in 1 BOX, UNIT-DOSE02/05/2020
    42.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    5NDC:17856-7014-5120 in 1 BOX, UNIT-DOSE02/05/2020
    51.25 mL in 1 SYRINGE; Type 0: Not a Combination Product
    6NDC:17856-7014-6120 in 1 BOX, UNIT-DOSE02/05/2020
    62.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    7NDC:17856-7014-750 in 1 BOX, UNIT-DOSE02/05/2020
    720.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    8NDC:17856-7014-850 in 1 BOX, UNIT-DOSE02/05/2020
    831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    9NDC:17856-7014-972 in 1 BOX, UNIT-DOSE03/20/2020
    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 not finalpart34310/01/2019
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-7014) , repack(17856-7014)