FDA Label for Diphenhydramine Hcl 12.5 Mg Per 5 Ml
View Indications, Usage & Precautions
Diphenhydramine Hcl 12.5 Mg Per 5 Ml Product Label
The following document was submitted to the FDA by the labeler of this product Aarna Usa 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.
Otc - Active Ingredient
Active ingredient (in each 5 mL)
Diphenhydramine HCl 12.5 mg
Otc - Purpose
Purpose
Antihistamine
Otc - When Using
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- runny nose
- itchy, watery eyes
- itchy of the nose or throat
Warnings
Warnings
Do not use
- with any other product containing diphenhydramine, even one used on skin
- to make a child sleepy
- a breathing problem such as chronic bronchitis
- glaucoma
- a sodium restricted diet
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitabillty may occur, especially in children
Ask a doctor before use if the child has
Ask a doctor or pharmacist before use if the child is
taking sedatives or tranquilizers.
When using this product
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- do not take more than 6 doses in any 24 hours
- take every 4 to 6 hours, or as directed by a doctor
- mL = milliliter
- keep dosing cup with product
- find the right dose on the chart below
Age (yr) | Dose (mL) |
children 6 to 11 years | 5 mL to 10 mL |
children 2 to 5 years | Do not use unless directed by a doctor |
children under 2 years | Do not use |
Other Safety Information
Other Information
each 5 mL contains:
sodium 8 mg
Store between 20°- 25°C (68°-77°F). Do not refrigerate
protect from light
Inactive Ingredient
Inactive Ingredients
anhydrous citric acid, bubble gum favor, purified water,sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.
Otc - Questions
Questions or comments?
Please Call 1(877) 225-6999
Manufactured for:
AARNA USA INC
Leland, NC 28451
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy
Package Label.Principal Display Panel
* Please review the disclaimer below.
