Active Ingredient (In Each 5Ml)
Diphenhydramine HCL 12.5mg
Childrens Allergy Relief
FDA Label NDC 73282-0125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calmco Llc for the product Childrens Allergy Relief (NDC 73282-0125). 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 5ml), purpose, uses, warnings, keep out of reach of children, do not use, directions, dosing chart, 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 upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Warnings
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
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)
Do Not Use
• to make a child sleepy • with any other product containing diphenhydramine, even one used on skin
Directions
- this product does not contain directions or complete warnings for adult use
- give the recommended number of vials below following the instructions under Easy to Use on the side panel
- do not take more than 6 doses in any 24 hour period
- empty each Single-Use Vial of all liquid when dosing
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. |
Other Information
- each Single-Use vial contains 16mg of sodium
- store at 68-77°F (20-25°C)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
Inactive Ingredients
citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum
Questions Or Comments?
941-202-3270 or visit www.DrKids.com
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