Children Allergy Relief Dye Free Cherry Solution
FDA Label NDC 50090-6163

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Children Allergy Relief Dye Free Cherry (NDC 50090-6163). 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, warnings, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(In Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose 
    • itchy, watery eyes
    • sneezing 
    • itching of the nose or throat

Warnings

.

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If The Child Has

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If The Child Is

taking sedatives or tranquilizers

When Using This Product

  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children


Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center right away

(1-800-222-1222).

Directions

  • find right dose on chart below
    • mL=milliliter
    • measure only with dosing cup provided
    • do not use dosing cup with other products
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

      • AGE(yr) DOSE(mL)
      children under  2 years  do not use
      children 2 to 5 years do not use unless directed by a doctor
      children 6 to 11 years 5 mL to 10 mL

Other Information

  • each 5 mL contains: sodium 5 mg
  • dosing cup provided 
  • store between 20 - 25oC (68o- 77oF)

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol.  

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

How Supplied

Product: 50090-6163

NDC: 50090-6163-0 118 mL in a BOTTLE / 1 in a CARTON

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