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Drug Facts
Childrens Dye Free Allergy Relief Liquid
FDA Label NDC 21130-563
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc. for the product Childrens Dye Free Allergy Relief (NDC 21130-563). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each 5 mL)
Diphenhydramine HCl 12.5 mg
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
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
Warnings
Otc - Do Not Use
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
- a breathing problem such as chronic bronchitis
- glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Otc - Keep Out Of Reach Of 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).
Dosage & Administration
Directions
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| Age (yr) | Dose (mL) |
| 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 |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Safety Information
Other information
- each 5 mL contains: sodium 5 mg
- store at no greater than 25°C
Inactive Ingredient
Inactive ingredients anhydrous citric acid, flavors, glycerin, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
653L Children's Dye Free Allergy Relief - Bubblegum flavor - Label
653L Children's Dye Free Allergy Relief - Bubblegum flavor - Carton
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