Drkids Children's Allergy Relief

Drkids Children's Allergy Relief
SPL v3
SPL
SPL Set ID e8450607-a68c-4729-e053-2995a90a2238
Route
ORAL
Published
Effective Date 2022-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Sucralose Xanthan Gum Glycerin Sorbitol Sodium Benzoate Trisodium Citrate Dihydrate Water Propylene Glycol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-01
Description

Diphenhydramine HCL 12.5mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL 12.5mg

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

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
Do Not Use

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

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
Package 20ct Pouch

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

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)

Active Ingredient (in Each 5ml)

Diphenhydramine HCL 12.5mg

Structured Label Content

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

Purpose

Antihistamine

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

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
Do Not Use (Do not use)

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

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 (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
Package 20ct Pouch (Package- 20ct pouch)

Inactive Ingredients (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? (Questions or comments?)

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

Keep Out of Reach of 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)

Active Ingredient (in Each 5ml) (Active Ingredient (in each 5mL))

Diphenhydramine HCL 12.5mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:02.432866 · Updated: 2026-03-14T23:01:15.754566