Label: MAX RELIEF JUNIOR- acetaminophen liquid

  • NDC Code(s): 71399-0021-4, 71399-0021-6, 71399-0021-8
  • Packager: Akron Pharma Inc.
  • 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 May 14, 2023

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  • 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

    Questions or comments? call toll-free 1-877-225-6999.

    Manufactured for:

    Akron Pharma, Inc.

    Fairfield, NJ 07004

    www.akronpharma.com

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

  • PRINCIPAL DISPLAY PANEL

    118

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  • INGREDIENTS AND APPEARANCE
    MAX RELIEF JUNIOR 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:71399-0021-41 in 1 PACKAGE05/14/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71399-0021-81 in 1 PACKAGE05/14/2023
    2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:71399-0021-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/14/2023
    Labeler - Akron Pharma Inc. (067878881)
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