Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Childrens Allergy Relief Solution
FDA Label NDC 70000-0701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Childrens Allergy Relief (NDC 70000-0701). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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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
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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
Leader 44-018 (Leader 44 018 1) 
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