Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Allergy Relief Solution
FDA Label NDC 50844-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Allergy Relief (NDC 50844-015). 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 6 doses in 24 hours
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
| 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 5 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
- protect from light
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose
Questions Or Comments?
1-800-426-9391
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QUALITY
+PLUS
NDC 50844-015-19
Compare to active ingredient
in Children’s Benadryl® Allergy*
CHILDREN’S
ALLERGY
RELIEF
Diphenhydramine HCl 12.5 mg
Antihistamine
Relieves
• Sneezing
• Runny nose
• Itchy, Watery eyes
• Itchy throat
or nose
Cherry
Flavor
8 FL OZ (237 mL)
ALCOHOL FREE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Benadryl® Allergy.
50844 ORG051901519
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-015 (Quality Plus 44 015 1)
* Please review the disclaimer below.
