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 Aptapharma 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.
Active Ingredient
Drug Facts
Active ingredient
(in each 5 mL teaspoon)
Diphenhydramine HCL 12.5 mg
Purpose
Antihistamine
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.
Uses
• temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• sneezing
• itching of the nose or throat
• runny nose
• itchy watery eyes
• temporarily relieves these symptoms due to the common cold:
• sneezing
• runny nose
Warnings
Do not use
• with any other product containing diphenhydramine, even one used on skin
• to make a child sleepy
Ask A Doctor Before Use If The Child Has
• glaucoma
• a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers
When Using This Product
• marked drowsiness may occur
• excitability may occur, especially in children
• sedatives and tranquilizers may increase drowsiness
Directions
• if needed, take every 4-6 hours
• do not take more than 6 doses in 24 hours
Children under 4 years of age: do not use
Children 4 to under 6 years of age: do not use unless directed by a doctor
Children 6 to under 12 years of age: 1 to 2 teaspoonfuls
(12.5 mg to 25 mg)
Other Information
• Keep carton for full directions for use
• each teaspoonful contains: sodium 10 mg
• store at 20-25 ° C (68-77 ° F)
• dosage cup provided
Inactive Ingredients
Citric acid, D and C Red # 33, FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
Call weekdays from 9:30 AM to 4:30 PM EST at
1-877-798-5944
Product Label
SOUND BODY™
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL® ALLERGY LIQUID*
Relieves: Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat
Children’s
Allergy
Relief
Diphenhydramine HCL Oral Solution Antihistamine
Alcohol-free
Cherry Flavor
4 FL OZ (118 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken, NJ 08110
V#5002632 ITEM#301
BX-034
LOT:
EXP:
* Please review the disclaimer below.