FDA Label for Childrens Allergy Relief
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
Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 |
| 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?
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0701-1
DYE-FREE
Children's
Allergy
Relief
Diphenhydramine HCl
12.5 mg / 5 mL Oral Solution
Antihistamine
Clear
Bubble Gum
Flavored Liquid
Ages 6 to 11 Years
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat
or Nose
Alcohol-Free
Sugar-Free
COMPARE TO
CHILDREN’S
BENADRYL®
DYE-FREE
ALLERGY LIQUID
active ingredient*
100% Money
Back Guarantee
4 FL OZ (118 mL)
*This product is not manufactured or distributed by Kenvue Inc., owner
of the registered trademark Children’s Benadryl® Dye-Free Allergy.
50844 ORG072401836
©2024 Cardinal Health. All Rights Reserved. CARDINAL
HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
LEADER, and the LEADER LOGO are trademarks or registered
trademarks of Cardinal Health. All other marks are the
property of their respective owners.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CardinalHealth™
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979
* Please review the disclaimer below.
