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 CalmCo 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

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

Dosing Chart

• Age (Years): Dose
• 6 - 11 years: 1 - 2 Single-Use Vials (5mL 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 16mg of sodium
• store at 68-77ºF (20-25ºC)
• 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?

941-202-3270 or visit www.DrKids.com

Package

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-0012
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-0012-1	20 in 1 CARTON	08/06/2021
1		5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/06/2021	12/31/2025

Labeler - CalmCo LLC (079308308)