Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Childrens Dye Free Allergy Relief Solution
FDA Label NDC 11822-0918
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Childrens Dye Free Allergy Relief (NDC 11822-0918). 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 |
| 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
SUGAR FREE
ALCOHOL FREE
Compare to the
active ingredient in
Children’s Benadryl®
Dye-Free Allergy*
NDC 11822-0918-1
AGES 6-11
CHILDREN’S
DYE-FREE
ALLERGY RELIEF
DIPHENHYDRAMINE
HCl 12.5 mg / 5 mL
Oral Solution
ANTIHISTAMINE
for relief of:
sneezing,
runny nose,
itchy throat or nose,
itchy, watery eyes
CLEAR BUBBLE
GUM FLAVOR
DOSAGE CUP INCLUDED
4 FL OZ (118 mL)
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Benadryl® Dye-Free Allergy.
50844 ORG012301836
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
SATISFACTION
GUARANTEE
If you’re not satisfied, we’ll
happily refund your money.
Rite Aid 44-018 (Rite Aid 44 018 1) 
* Please review the disclaimer below.
