FDA Label for Allergy Relief Childrens
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 REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Allergy Relief Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Walmart 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
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.
Directions
- do not take more than directed
- do not take more than 6 doses in 24 hours
- mL = milliliter
- only use the dose cup provided
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
| 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 |
Other Information
- each 5 mL contains: sodium 4 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum
Questions Or Comments?
1-888-287-1915
Principal Display Panel
equate™
NDC 79903-368-04
Compare
to Children’s
Benadryl®
Dye-Free Allergy
active
ingredient*
children's
ALLERGY
RELIEF
Diphenhydramine HCl,
12.5 mg per 5 mL
Oral Solution
Antihistamine
Sugar-Free
Dye-Free
6-11 YEARS
Relieves:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat
or Nose
4-6
HOURS/
DOSE
Clear
Bubble Gum
Flavored
Dosage Cup
Included
4 FL OZ (118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
DISTRIBUTED BY: Walmart Inc.
Bentonville, AR 72716
PRODUCT OF CHINA
*This product is not manufactured or distributed
by Kenvue Inc., owner of the registered trademark
Children’s Benadryl® Dye-Free Allergy.
50844 ORG072401836
* Please review the disclaimer below.
