Active Ingredient(S)
Diphenhydramine HCl 12.5 mg in each 5ml
Childrens Allergy Relief Liquid
FDA Label NDC 69168-471
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Childrens Allergy Relief (NDC 69168-471). 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(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, 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
Use(S)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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
- 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
- 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
- do not take more than directed
- do not take more than 6 doses in 24 hours
- mL = milliliter
- only use the dosing cup provided
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
- 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 4 mg
store at 25°C (77°F); excursions permitted between 15-30°C (59°-86°F)
see end flap lot expiration date and lot number
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium
benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum
Questions/Comments
Call 1-888-952-0050 Monday Through Friday 9AM – 5PM EST.
Principal Display Panel
Children's Allergy Carton (471 Childrens Allergy Relief 1)
Children's Allergy Label (471 Childrens Allergy Relief 2)
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