FDA Label for Cvs Dye-free Childrens Allergy
View Indications, Usage & Precautions
Cvs Dye-free Childrens Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 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 nose or throat
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 | 5 mL 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 3 mg• store at room temperature• protect from sunlight• see bottom panel for lot number and expiration date• contains low sodium
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 51316-710-08
*Compare to the active ingredient in Children'sBenadryl® Dye-Free*
Dye-Free
Children’s Allergy Relief
Diphenhydramine HCl l Antihistamine
Oral Solution
For Relief Of:
• Runny nose• sneezing• itchy, watery eyes• Itchy Throat or Nose
Sugar Free
8 FL. OZ. (236 mL)
Distributed by:
*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.
* Please review the disclaimer below.