Diphenhydramine Hydrochloride
Diphenhydramine Hydrochloride
4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4
HUMAN OTC DRUG LABEL
Sep 12, 2025
Precision Dose, Inc.
DUNS: 035886746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 25 mg Tablet Blister Pack Carton Label
PrecisionDose™
NDC 68094-018-61
Unit Dose
diphenhydrAMINE HCl
25 mg Tablets
100 Tablets
(10x10)
Each tablet contains:
Diphenhydramine Hydrochloride 25 mg
Calcium 20 mg
Gluten Free
USUAL DOSE: SEE ENCLOSED DRUG FACTS.
Store at 20-25°C (68-77°F).
Avoid high humidity. Protect from light.
Keep out of reach of children.
Hospital Use Only.
LC1733
R0
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of nose
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
HOW SUPPLIED SECTION
How Supplied
They are supplied as follows:
NDC 68094-018-61
Unit Dose Packages of 100 Tablets (10×10) per Carton
SPL UNCLASSIFIED SECTION
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com
LI1729 Rev. 10/24
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Diphenhydramine 25 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
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 you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
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).
DOSAGE & ADMINISTRATION SECTION
Directions
*Use as directed per healthcare professional.
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
|
adults and children 12 years and older |
1 to 2 tablets |
|
children 6 to under 12 years |
1 tablet |
|
children under 6 years |
do not use |
STORAGE AND HANDLING SECTION
Other information
*each tablet contains: calcium 20 mg
- store at 20-25°C (68-77°F).
- Avoid high humidity. Protect from light
- small tablet size, easy to swallow
INACTIVE INGREDIENT SECTION
Inactive ingredients
carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-397-9228