Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Max Allergy Kids Solution
FDA Label NDC 71399-0023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc. for the product Max Allergy Kids (NDC 71399-0023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itchy of the nose or throat
Do Not Use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
Ask A Doctor Before Use If The Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium restricted diet
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitabillty may occur, especially in children
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
| Age (yr) | Dose (mL) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | Do not use unless directed by a doctor |
| children under 2 years | Do not use |
Other Information
- each 5 mL contains: sodium 8 mg
- store between 20°- 25°C (68°-77°F). Do not refrigerate
- protect from light
Inactive Ingredients
anhydrous citric acid, bubble gum flavor, purified water, sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.
Questions Or Comments?
Please Call 1(877) 225-6999
Manufactured for:
Akron Pharma, Inc,
Fairfield, NJ 07004
Manufactured in U.S.A
* Please review the disclaimer below.
