CHILDRENS ALLERGY RELIEF- diphenhydramine 12.5mg/5ml 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]

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

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)

Do not use

to make a child sleepy with any other product containing diphenhydramine, even one used on skin

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.

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

Inactive ingredients

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

Questions or comments?

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

Package- 20ct pouch

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine 12.5mg/5ml solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-0125(NDC:70302-127)
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
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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: 73282-0125-1	20 in 1 POUCH	01/01/2022
1		5 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2022

Labeler - CalmCo LLC (079308308)

Registrant - CalmCo LLC (079308308)