Childrens Allergy

Childrens Allergy
SPL v11
SPL
SPL Set ID c639a36d-c683-4a4d-90b7-eadec7464aa2
Route
ORAL
Published
Effective Date 2024-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucrose D&c Red No. 33 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-02-03

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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
Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on the chart below
age (yr) dose (mL)
 children 6 to 11 years  5 mL to 10 m
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years  do not use


Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Product Label

 

Other Information
  • each 5 mL contain: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used
Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40 flavor glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments?

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

FOR AGES 6-11 YEARS

Children's Allergy Relief

Diphenhydramine HCl 12.5 mg - Antihistamine

CHERRY FLAVOR

Compare toChildren's Benadryl® Allergy active ingredient*

  • Relief of: Runny nose, sneezing, itching of the nose or throat & itchy, watery eyes
  • Alcohol free
  • Dosing cup included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Children's Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children.

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

Ask A Doctor Before Use If the Child Has
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If the Child Is

taking sedatives or tranquilizers.


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

Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on the chart below
age (yr) dose (mL)
 children 6 to 11 years  5 mL to 10 m
 children 2 to 5 years  do not use unless directed by a doctor
 children under 2 years  do not use


Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Product Label

 

Other Information (Other information)
  • each 5 mL contain: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate.
  • protect from light. Store in outer carton until contents are used
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, FD&C red #40 flavor glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions Or Comments? (Questions or comments?)

 Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

FOR AGES 6-11 YEARS

Children's Allergy Relief

Diphenhydramine HCl 12.5 mg - Antihistamine

CHERRY FLAVOR

Compare toChildren's Benadryl® Allergy active ingredient*

  • Relief of: Runny nose, sneezing, itching of the nose or throat & itchy, watery eyes
  • Alcohol free
  • Dosing cup included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Children's Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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