FDA Label for Kids Allergy
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Kids Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Genexa Inc.. 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.
Other
Drug Facts
Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.
Patent Pending | Distributed by: Genexa Inc.
Los Angeles, CA 90034 | genexa.com
Made in the USA with globally sourced ingredients.
NDC 69676-0039-9
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 you have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
- use only with enclosed dose cup. Do not use with any other dosing device.
adults and children 12 years of age and over | 10 20 mL |
children 6 to under 12 years | 5 - 10 mL |
children 2 to under 6 years | do not use unless directed by a doctor |
children under 2 years | do not use |
Storage And Handling
Other information
store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients organic agave syrup, natural citric extract, purified water
Otc - Questions
Questions?
1-855-436-3921 Mon.-Fri. 7am - 6pm PST
Package Label.Principal Display Panel
Genexa
REAL MEDICINE MADE CLEAN
Kids' Allergy
Runny Nose
Itchy Nose
Sneezing
Itchy Eyes
Watery Eyes
Itchy Throat
Diphenhydramine HCl
Antihistamine
Flavored with Organic Agave Syrup
No allergens, dyes, or parabens
Ages 6+ Dosing cup included
4 FL OZ (118 mL) Liquid
* Please review the disclaimer below.