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

art file of 20ct pouch

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2022

Labeler - CalmCo LLC (079308308)

Registrant - CalmCo LLC (079308308)

DrKids Children's Allergy Relief