FDA Label for Max Relief Junior

View Indications, Usage & Precautions

Max Relief Junior Product Label

The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient (in each 5 mL)

Acetaminophen 160 mg


Otc - 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.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Otc - Pregnancy Or Breast Feeding



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


Other



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.


Otc - 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.


* Please review the disclaimer below.