Label: MAX RELIEF JUNIOR- acetaminophen liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • PURPOSE

    Purpose

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses

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

    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.

    Soar throat warning: if sore throat is severe, persists or 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 nonprescription). 
    • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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 (see overdose warning)

    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

    Keep out of reach of children.

  • PREGNANCY OR BREAST FEEDING

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

  • SPL UNCLASSIFIED SECTION

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

  • DOSAGE & ADMINISTRATION

    Directions

    • this product does not contain direction or complete warnings for adult use
    • Shake well before using
    • ml = milliliter
    • find 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 hourswhile 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 (yrs.) Dose (tsp or mL)
     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 15o-30oC (59o-86oF). Protect from Freezing. Protect from light.

  • INACTIVE INGREDIENT

    Inactive ingredients: amydrous citric acid, bubble gum flavor, glycerin, polyethylene glycol400, punfied water, saccharin sodium, sodium benzoate, sodium citrate, sorbttol solution, sucralose.

  • QUESTIONS

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAX RELIEF JUNIOR 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0025(NDC:71399-0021)
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0025-150 in 1 BOX, UNIT-DOSE02/28/2024
    1NDC:17856-0025-520.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-0025-272 in 1 BOX, UNIT-DOSE02/28/2024
    2NDC:17856-0025-65 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:17856-0025-372 in 1 BOX, UNIT-DOSE02/28/2024
    3NDC:17856-0025-715 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:17856-0025-448 in 1 BOX, UNIT-DOSE02/28/2024
    4NDC:17856-0025-85 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 DrugM05/14/2023
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0025)