Otc - Active Ingredient
Active ingredient (in each 5 mL)
Diphenhydramine HCl 12.5 mg
Diphenhydramine Hcl 12.5 Mg Per 5 Ml Solution
FDA Label NDC 82568-0016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Diphenhydramine Hcl 12.5 Mg Per 5 Ml (NDC 82568-0016). 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 otc - active ingredient, otc - purpose, otc - when using, warnings, indications & usage, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
