DR KIDS ALLERGY RELIEF- diphenhydramine hcl solution

Dr Kids by

Drug Labeling and Warnings

Dr Kids 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 and Purpose

• Active ingredient (in each 5 mL vial): Purpose
• Diphenhydramine HCl 12.5 mg...............: Antihistamine

Uses

Temporarily relieves

• runny nose
• sneezing
• itchy, watery eyes due to hay fever
• itchy nose or throat
• other upper respiratory allergies

Warnings

.

Do not use

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if your child has

• glaucoma
• a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if your child is

taking sedatives or tranquilizers

When using this product

• may cause excitability in children
• may cause marked drowsiness
• sedatives and tranquilizers may increase the drowsiness effect

KEEP OUT OF REACH OF CHILDREN.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• do not exceed 12 vials in a 24-hour period
• follow the “Easy to Use” instructions on pouch

• Age: Dose
• children 6 to 12 years: 1 - 2 vials every 4-6 hours
• children under 6 years: consult a doctor

Other information

• each 5 mL vial contains: sodium 2 mg
• store between 68-77°F (20-25°C)
• do not use if pouch has been torn open or vial is punctured or open

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose, flavors, glycerin, propylene glycol, sodium benzoate, sorbitol, sucralose, xylitol, water

Questions or comments?

(M-F) 9AM-5PM EST or visit www.DrKids.com

Distributed by: CalmCo LLC, Sarasota, FL 34240

Principal Display Panel

INGREDIENTS AND APPEARANCE

DR KIDS  ALLERGY RELIEF
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73282-2521
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73282-2521-2	20 in 1 POUCH	01/20/2025	01/20/2025
1		5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 73282-2521-1	24 in 1 POUCH	01/20/2025
2	NDC: 73282-2521-5	5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3	NDC: 73282-2521-3	30 in 1 POUCH	10/01/2025
3	NDC: 73282-2521-5	5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
4	NDC: 73282-2521-4	48 in 1 POUCH	10/01/2025
4	NDC: 73282-2521-5	5 mL in 1 VIAL, SINGLE-DOSE; 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	01/20/2025

Labeler - CalmCo LLC (079308308)