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Drug Facts
Benadryl Allergy Solution
FDA Label NDC 50580-573
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 (NDC 50580-573). 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 5 ml), purpose, uses, do not use, ask a doctor before use if the user has, 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 5 Ml)
Diphenhydramine HCl 12.5 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 The User Has
- a breathing problem such as chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is 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
- find right dose on chart below
- mL = milliliter
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 doses in 24 hours
| Age (yr) | Dose (mL) |
| adults and children
12 years and over | 10 mL to 20 mL (2x10 mL;
Note: dosing cup needs to be filled to 10 mL line twice for the 20 mL dose) |
| children 6 to 11 years | 5 mL to 10 mL |
| children 2 to 5 years | do not use unless directed
by a doctor |
| children under 2 years | do not use |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
■ each 5 mL contains:
sodium 14 mg
■ store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
■
do not use if carton is opened
■ do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
Inactive Ingredients
anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose
Questions Or Comments?
call 1-877-717-2824 or 215-273-8755 (collect)
Principal Display Panel
NDC 50580-573-04
NEW DOSING FOR ADULTS
Benadryl
®
ALLERGY
LIQUID
Diphenhydramine HCl/antihistamine
12.5 mg/5 mL oral solution
Same as Children’s Benadryl® Allergy Liquid
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Alcohol Free
Wild Cherry
Flavored Liquid
4 fl oz (118 mL)
* Please review the disclaimer below.
