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 Cardinal Health. 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.
Other
Drug Facts
Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl USP 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 throat or nose
Otc - Do Not Use
Do not use
• to make a child sleepy• with any other product containing diphenhydramine, even one used on skin
Otc - Ask Doctor
Ask a doctor before use if the child has
• a breathing problem such as chronic bronchitis• glaucoma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
• marked drowsiness may occur• sedatives and tranquilizers may increase drowsiness• excitability may occur, especially in children
Otc - 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 1-800-222-1222
Directions
• find right dose on chart below• take every 4 to 6 hours, or as directed by a doctor• do not take more than 6 doses in 24 hours• ml = milliliter
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 | 5mL to 10 mL |
Attention: use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
Other Information
• each 5 mL contains: sodium 11 mg• store at room temperature• see bottom panel for lot number and expiration date• protect from light• contains low sodium
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, FD&C red 40, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
LEADER™
NDC 70000-0245-2
Children’s Allergy Relief
Diphenhydramine HCl ǀ Antihistamine
12.5 mg/5 mL Oral solution
COMPARE TO CHILDREN'S
BENADRYL® active ingredient*
Cherry Flavor
For Relief of:
8 FL OZ (236 mL)
DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl®.
IMPORTANT: Keep this carton for future reference on full labeling. |
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
1-800-200-6313
Essential to Care™ since 1979
All Leader Brand Products have a 100% Money Back Guarantee
Return to place of purchase if not satisfied
* Please review the disclaimer below.