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Drug Facts
Benadryl Allergy Extra Strength Tablet, Film Coated
FDA Label NDC 50580-533
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Benadryl Allergy Extra Strength (NDC 50580-533). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Diphenhydramine HCl 50 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
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
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
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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. (1-800-222-1222)
Directions
- 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 tablet |
| children under 12 years | do not use |
Other Information
- each tablet contains: calcium 35 mg
- store between 20-25°C (68-77°F). Protect from light.
- do not use if blister unit is torn or broken
Inactive Ingredients
carnauba wax, croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions Or Comments?
call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NEW NDC 50580-533-24
Benadryl ®
ALLERGY
EXTRA STRENGTH
Diphenhydramine HCl 50mg | Antihistamine
✓ Sneezing ✓ Runny Nose
✓ Itchy, Watery Eyes ✓ Itchy Throat
actual size
24 TABLETS
Benadryl-01 (Benadryl 01)
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