Label: ACETAMINOPHEN elixir

  • 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 13, 2023

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  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    trmporarily:

    • reduces fever
    • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • Warnings

    Liver warning

    This product contains acetaminophen.

    Severe liver damage may occur if your child takes:

    • more than 5 doses in 24 hours, which is the maximum daily amount 
    • with other drugs containing acetaminophen.

    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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if your child has

    • liver disease

    Ask a doctor or pharmacist before use if your child is 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 5 days
    • 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.

    Keep out of reach of children.

    Overdose Warning:

    In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical
    attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • shake well before using
    • mL=milliliter
    • find the right dose on chart below, if possible, use weight to dose; otherwise use age
    • use only the enclosed dosing cup designed for use with this product.
    • Do not use any other dosing device. 
    • if needed, repeat dose every 4 hours while symptoms last 
    • do not give more than 5 times in 24 hours 
    • do not give more than 5 days unless directed by doctor.
    Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
     under 24 under 2 ask a doctor
     24 to 35 2 to 3 1 tsp or 5 mL
     36 to 47 4 to 5 1 1/2 tsp or 7.5 mL
     48 to 59 6 to 8 2 tsp or 10 mL
     60 to 71 9 to 10 2 1/2 tsp or 12.5 mL
     72 to 95 11 3 tsp or 15 mL

  • Other information

    • Store at room temperature 15°-30° C (59°-86°F)
    • Protect from Freezing. 
    • Protect from Light.
  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

  • Inactive Ingredients:

    bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.

    Questions or Comments?

    Call (877) 225-6999 Monday - Friday 9AM-5PM EST

    DISTRIBUITED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

    * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0166(NDC:71399-0160)
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0166-172 in 1 BOX, UNIT-DOSE03/13/2023
    1NDC:17856-0166-210.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-0166-350 in 1 BOX, UNIT-DOSE03/13/2023
    2NDC:17856-0166-420.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:17856-0166-750 in 1 BOX, UNIT-DOSE03/13/2023
    3NDC:17856-0166-831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:17856-0166-572 in 1 BOX, UNIT-DOSE03/13/2023
    4NDC:17856-0166-615 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 finalpart34305/18/2021
    Labeler - ATLANTIC BIOLOGICALS CORP (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0166)
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