Active Ingredient
(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5mg
Kosher Meds Childrens Allergy Relief Solution
FDA Label NDC 82179-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mollec Inc for the product Kosher Meds Childrens Allergy Relief (NDC 82179-004). 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, purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, 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 respiratory allergies:
- sneezing
- itching of the nose or throat
- runny nose
- itchy watery eyes
- temporarily relieves these symptoms due to the common cold:
- sneezing
- runny nose
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- glaucoma
- a breathing problem such as chronic bronchitis
- marked drowsiness may occur
- excitability may occur, especially in children
- sedatives and tranquilizers may increase drowsiness
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers
When using this product
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- if needed, take every 4-6 hours
- do not take more than 6 doses in 24 hours
| Children under 4 years of age: | do not use |
| Children 4 to under 6 years of age: | do not use unless directed by a doctor |
| Children 6 to under 12 years of age: | 1 to 2 teaspoonfuls (12.5 mg to 25 mg) |
Other Information
- Keep carton for full directions for use
- each teaspoonful contains: sodium 10 mg
- store at 20° - 25° C (68° - 77° F)
- dosage cup provided
Inactive Ingredients
Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Product Label
Image Description (Updated 004 1)
Image Description (Updated 004 2)
* Please review the disclaimer below.
