FDA Label for Childrens Allergy Relief
View Indications, Usage & Precautions
Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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(S)
Diphenhydramine HCl 12.5 mg in each 5ml
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.
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