CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution

Childrens Allergy Relief by

Drug Labeling and Warnings

Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by New Vision Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each 5mL)

Diphenhydramine HCL 12.5mg

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

Warnings

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 your child has

 a breathing problem such as chronic bronchitis 

 glaucoma

 a sodium-restricted diet

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. (1-800-222-1222)

Directions

 do not take more than 6 doses in any 24 hour period give the recommended number of vials below following the instructions under How to Open and Use on the side panel empty each Single-Use Vial required, of all liquid when dosing  this product does not contain directions or complete warnings for adult use.

                                                                                    Dosing Chart

• Age (Years): Dose
• 6 – 11 years: 1 – 2 Single-Use Vials (5 mL Each) Every 4-6 hours. Do not exceed 12 Vials in 24 hours.

Inactive Ingredients

citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sorbitol, strawberry flavor, sucralose, tri-sodium citrate, xanthan gum.

Other Information

• each Single-Use Vial contains 6mg of sodium
• store at 20-25ºC (68-77ºF)
• tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

Questions or Comments?

+1-954-721-5000 M-F 9am-6pm

Package Labeling:

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70302-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70302-012-20	20 in 1 BOX	11/01/2018
1		5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/01/2018

Labeler - Unipharma, LLC (079524332)

Establishment
Name	Address	ID/FEI	Business Operations
Unipharma, LLC		079524332	manufacture(70302-012)