Diphenhydramine
- Dosage form
- TABLET, COATED
- Labeler
- AAA Pharmaceutical, Inc.
- Label updated
- 2024-12-02
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
Label information
Drug Facts
Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg
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
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Warnings
Label information
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Label information
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
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4 to 6 hours
- do not exceed 6 doses in 24 hours
| adults and children 12 years of age and over | 25 mg to 50 mg (1 to 2 tablets) |
| children 6 to under 12 years of age | 12.5 mg 12.5 mg dosage strength is not available in this package. Do not attempt to break tablets. to 25 mg (1 tablet) |
| children under 6 years of age | ask a doctor |
Other information
- each tablet contains: calcium 45 mg
- store at room temperature 15°-30°C (59°-86°F)
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
PRINCIPAL DISPLAY PANEL
RESTORE U
NDC 57344-090-02
†COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATABS®
Allergy Relief
Antihistamine
Diphenhydramine HCl
Easy To Swallow
Relieves: • Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat
48 TABLETS
[Image in the official label — see DailyMed source]
DailyMed Set ID: 76724432-ff3c-404f-ba1f-5af68e3ab8c4 · Version 5
NDC: 57344-090