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 Calmco Llc. 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 (In Each 5Ml)
Diphenhydramine HCL 12.5mg
Purpose
Antihistamine
Uses
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 Your 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
• excitability may occur, especially in children
Overdosage
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 6 doses in any 24 hour period
- give the recommended number of vials below following the instructions under How to Open and Use on the side panel
- empty each Single-Use Vial of all liquid when dosing
- this product does not contain directions or complete warnings for adult use
Dosing Chart
Age (Years) | Dose |
6 - 11 years | 1 - 2 Single-Use Vials (5mL each) every 4-6 hours. Do not exceed 12 vials in 24 hours |
Inactive Ingredients
citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum
Other Information
- each Single-Use vial contains 16mg of sodium
- store at 20-25°C (68-77°F)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
Questions Or Comments?
+1-954-721-5000 • M-F 9am-6pm
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