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 Akron Pharma Inc.. 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.

Active Ingredient



Active ingredient (in each 5mL)                                            Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer


Uses



temporarily: 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 then 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, persist 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.
      • if your child is allergic to acetaminophen or anyof the inactive ingredients in this product.

Ask A Doctor Or Pharmacist Before Use If The Child Has



liver disease.


Ask  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 for more then 5 days
  • fever gets worse or last for more then 3 days
  • new symptoms occur redness or swelling is present. These could be signs of a serious condition. 

Overdose Warning:



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


Keep Out Of Reach Of Children




Directions



  • this product does not contain directions 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 product.
  •  Weight (lbs) Age (yrs.) Dose (tsp or mL)Weight (lbs)  Age (yrs.)Dose (tsp or mL) 
     under 24 under 2 ask a doctor 48 to 59 6 to 8 2 tsp or 10 mL
     25 to 35 2 to 3 1 tsp or 5 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL
     36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 72 to 95 11 2 1/2 tsp or 12.5 mL


Other Information



  • Store at room temperature 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

Inactive Ingredients



Anhydrous Citric Acid, Cherry Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.


Questions Or Comments?



call toll-free 1-877-225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com


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