FDA Label for Childrens Allergy
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
- KEEP OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Childrens Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Safeway, 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 (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
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 The Child Has
- glaucoma
- a breathing problem such as chronic bronchitis
- 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 The Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
| age (yr) | dose (mL) |
| children 6 to 11 years | 5 mL to 10 m |
| children 2 to 5 years | do not use unless directed by a doctor |
| children under 2 years | do not use |
Other Information
- each 5 mL contain: sodium 6 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
- protect from light. Store in outer carton until contents are used
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40 flavor glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
Call 1-888-723-3929 Monday-Friday 7AM-6PM PST
Principal Display Panel
FOR AGES 6-11 YEARS
Children's Allergy Relief
Diphenhydramine HCl 12.5 mg - Antihistamine
CHERRY FLAVOR
Compare to Children's Benadryl® Allergy active ingredient*
- Relief of: Runny nose, sneezing, itching of the nose or throat & itchy, watery eyes
- Alcohol free
- Dosing cup included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Children's Benadryl® Allergy.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Product Label
* Please review the disclaimer below.
