Drkids Children's Allergy Relief (la)

Drkids Children's Allergy Relief (la)
SPL v4
SPL
SPL Set ID 28ec213e-fabb-28ec-e063-6394a90ad102
Route
ORAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Sucralose Anhydrous Citric Acid Sorbitol Sodium Benzoate Glycerin Water Propylene Glycol Xylitol Carboxymethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-01-20 Until 2025-01-20

Description

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


Medication Information

Description

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
Section 55105-1
Active ingredient (in each 5 mL vial) Purpose
Diphenhydramine HCl 12.5 mg............... Antihistamine

Warnings

.

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

Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
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

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).

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


Structured Label Content

Uses

Temporarily relieves

  • runny nose
  • sneezing
  • itchy, watery eyes due to hay fever
  • itchy nose or throat
  • other upper respiratory allergies
Section 55105-1 (55105-1)
Active ingredient (in each 5 mL vial) Purpose
Diphenhydramine HCl 12.5 mg............... Antihistamine

Warnings

.

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

Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Distributed by: CalmCo LLC, Sarasota, FL 34240

Principal Display Panel

When Using This Product (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. (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).

Ask A Doctor Before Use If Your Child Has (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 (Ask a doctor or pharmacist before use if your child is)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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