Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Diphenhydramine Hcl Solution
FDA Label NDC 60687-829
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Diphenhydramine Hcl (NDC 60687-829). 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, 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
- a breathing problem such as chronic bronchitis
- glaucoma
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. (1-800-222-1222)
Directions:
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| 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 |
Other Information
- each 5 mL contains: sodium 10 mg
- store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
5 mL unit dose cups: 100 cups (10 x 10) NDC 60687-829-86
Inactive Ingredients:
citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.
Questions Or Comments?
Call 1-800-845-8210
DO NOT USE IF SEAL IS BROKEN.
Distributed by:
American Health Packaging
Columbus, OH 43217
R02/24
Principal Display Panel - Label
Diphenhydramine Hydrochloride Oral Solution Usp Label (Label)
100 Count Case NDC 60687-829-86
Cup NDC 60687-829-40
Diphenhydramine Hydrochloride
Oral Solution USP
12.5 mg/5 mL
Antihistamine/Allergy
Alcohol Free/Dye Free/Sugar Free
Usual Dosage: See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
For Institutional Use Only
10 x 5 mL Unit-Dose Cups
T0865C050224 R02/24
Principal Display Panel – Cup – 12.5 Mg/5 Ml
12.5 mg/5 mL Diphenhydramine Hydrochloride Oral Solution Usp Cup Label (A0865c050224 Diphenhydramine HCl 12 5mg 5ml V1 Image)
NDC 60687- 829-40
Diphenhydramine
Hydrochloride
Oral Solution USP
12.5 mg/5 mL
Antihistamine/Allergy
Alcohol Free/Dye Free/Sugar Free
Delivers 5 mL
Sodium Content: 10 mg/5 ml
See package Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
A0865C050224
* Please review the disclaimer below.
