Childrens allergy solution

Drug facts

Active ingredient [in each5 mL]

Diphenhydramine HCl, USP12.5 mg

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

Do not use

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

Ask a doctor before use if the child has

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you

aretaking sedatives or tranquilizers

When using this product

  • sedatives and tranquilizers may increase drowsiness
  • marked drowsiness may occur
  • excitability may occur, especially in children

Keep out of reach of children.

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

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • mL = milliliter

Age (yr)
Dose (mL)
children under 6 years of age
ask a doctor
children 6 years to under 12 years of age
5 mL to 10 mL

Attention:Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each 5 mL contains:sodium 9 mg
  • store between 20-25C (68-77F). Protect from light. Store in outer carton until contents used
  • see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution


Questions or comments?
1-855-274-4122


Distributed By
Amerisource Bergen
1300 Morris Drive
Chesterbrook, PA 19087
Visit us at
www.mygnp.com

Ingredients and appearance - Product information

Childrens allergy solution- Diphenhydramine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 46122-361
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Glycerin ( UNII: PDC6A3C0OX)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color WHITE (Colorless) Flavor BUBBLE GUM

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Amerisource Bergen( 007914906)

Establishment

Name ID/FEI Business Operations
Amerisource Bergen 007914906 MANUFACTURE( 46122-361)

Package label-principal display panel - 4 fl oz (118 ml bottle)

NDC 46122-361-26

Compare to
Children's Benadryl ®
active ingredient*

GOOD
NEIGHBOR
PHARMACY ®

Children's
ALLERGY

Antihistamine

diphenhydramine hydrochloride
12.5 mg/5 mL oral solution
liquid medication

Relieves:

  • Runny Nose
  • Sneezing
  • Itchy, Watery Eyes
  • Itchy Throat

Sugar & Alcohol Free

Dye-Free
Bubble Gum Flavored

4fl OZ
(118 mL)