Active Ingredient (In Each Capsule)
Diphenhydramine HCl 50 mg
Benadryl Allergy Extra Strength Liqui-gels Capsule, Liquid Filled
FDA Label NDC 50580-322
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 Liqui-gels (NDC 50580-322). 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 active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- temporarily relieves these symptoms due to the common cold:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
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
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- avoid alcoholic drinks
If Pregnant Or Breast-Feeding
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)
Directions
- 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 over | 1 capsule |
| children under 12 years | do not use |
Other Information
- store between 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light.
- do not use if blister unit is torn or broken
Inactive Ingredients
FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, purified water, sorbitan, sorbitol
Questions Or Comments?
call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)
Principal Display Panel
NEW
NDC 50580-322-20
Benadryl ®
ALLERGY ®
EXTRA STRENGHT
LIQUI GELS ®*
Diphenhydramine HCl 50 mg
Antihistamine
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat
*liquid-filled capsules
Actual Size
20 CAPSULES
Benadryl_1.jpg (Benadryl 1)
* Please review the disclaimer below.
