Diphenhydramine HCl
Rugby 44-329
6c4f280d-9a98-40c3-a459-4220cf34c313
HUMAN OTC DRUG LABEL
Sep 15, 2025
Rugby Laboratories
DUNS: 079246066
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
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
Rugby®
NDC 0536-1214-29
compare to the active ingredient in
Benadryl® Allergy ULTRATABS®*
diphenhydramine HCl
diphenhydramine HCl 25 mg
antihistamine/allergy relief
relieves:
• sneezing • runny nose
• itchy throat
• itchy, watery eyes
100 tablets
actual size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
** SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**
*This product is not manufactured or distributed by Kenvue Inc., owner of the
registered trademark Benadryl® Allergy ULTRATABS®.
50844 REV0721C32912
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Rev. 07/25
R-17
Re-order No. 370672
Rugby 44-329
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391
DOSAGE & ADMINISTRATION SECTION
Directions
*do not take more than directed
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
|
adults and children 12 years and over |
1 to 2 tablets |
|
children 6 to under 12 years |
1 tablet |
|
children under 6 years |
do not use |
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Diphenhydramine HCl 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
- difficulty in urination due to enlargement of the 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 beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution 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.
STORAGE AND HANDLING SECTION
Other information
*each tablet contains: calcium 30 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- use by expiration date on package