FDA Label for Diphenhydramine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 48 TABLET CARTON
Diphenhydramine Product Label
The following document was submitted to the FDA by the labeler of this product Aaa Pharmaceutical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
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
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
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 - 48 Tablet Carton
RESTORE u
NDC 57344-090-02
†COMPARE TO THE ACTIVE
INGREDIENT IN BENADRYL®
ALLERGY ULTRATABS®
Allergy Relief
Antihistamine
Diphenhydramine HCI
Easy To
Swallow
Relieves: • Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Throat
48 TABLETS
* Please review the disclaimer below.