Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Allergy Relief Solution
FDA Label NDC 55319-918
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar Services Inc for the product Allergy Relief (NDC 55319-918). 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 5 ml), purpose, uses, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, keep out of reach of children., 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:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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 Child Has
- glaucoma
- a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- find right dose on chart below
- mL = milliliter
- only use the dose cup provided
- 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) |
| children under 2 years | do not use |
| children 2 to 5 years | do not use unless directed by a doctor |
| children 6 to 11 years | 5 mL to 10 mL |
Other Information
- each 5 mL contains: sodium 4 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
FAMILY
Wellness™
*COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL®
DYE-FREE ALLERGY
children's
DYE-FREE
ALLERGY RELIEF
AGES
6 TO 11
YEARS
Diphenhydramine HCl,
12.5 mg
per 5 mL Oral Solution
Antihistamine
Relieves:
•Sneezing • Itchy, watery eyes
• Runny nose • Itchy nose or throat
Alcohol-free
Sugar-free
DYE-FREE
BUBBLE GUM
FLAVOR
4 FL OZ
(118 mL)
NDC 55319-918-36
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Children’s Benadryl®
Dye-Free Allergy. 50844 ORG012301836
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PKWY
CHESAPEAKE, VA 23320 USA
NOT 100% SATISFIED?
Return within 30 days to the
store of purchase for a refund
(with receipt) or exchange.
Family Wellness 44-018 (Family Wellness 44 018 1)
* Please review the disclaimer below.
