Diphenyhydramine Hcl Oral Solution, Usp
1b591e27-b00b-41c8-9fe9-c633aba09134
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Drug Facts
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
Section 42229-5
Drug Facts
Do No Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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° to 25°C (68° to 77°F).
Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
NDC 0904-7560-41: 5 mL unit dose cup, in a tray of 10 cups.
NDC 0904-7559-66: 10 mL unit dose cup, in a tray of 10 cups.
Active Ingredient
Diphenhydramine HCl 12.5 mg
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
R02/25
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel
Delivers 5 mL
NDC0904-7560-41
Diphenydramine HCl Oral Solution USP
12.5 mg/5 mL
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)
Ask A Doctor Before Use If the Child Has
- a breathing problem such as chronic bronchitis
- glaucoma
Structured Label Content
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
Section 42229-5 (42229-5)
Drug Facts
Purpose
Antihistamine
Do No Use (Do no use)
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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 (Other information)
- each 5 mL contains: sodium 10 mg
- store between 20° to 25°C (68° to 77°F).
Diphenhydramine HCl Oral Solution, USP is a clear, cherry flavored liquid supplied in the following:
NDC 0904-7560-41: 5 mL unit dose cup, in a tray of 10 cups.
NDC 0904-7559-66: 10 mL unit dose cup, in a tray of 10 cups.
Active Ingredient (Active ingredient )
Diphenhydramine HCl 12.5 mg
Inactive Ingredients: (Inactive ingredients:)
citric acid anhydrous, glycerin, flavoring, purified water, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sorbitol.
Questions Or Comments? (Questions or comments?)
Call 1-800-845-8210
R02/25
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Delivers 5 mL
NDC0904-7560-41
Diphenydramine HCl Oral Solution USP
12.5 mg/5 mL
When Using This Product (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. (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)
Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
- a breathing problem such as chronic bronchitis
- glaucoma
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:44.497116 · Updated: 2026-03-14T23:09:41.311223