Skip to Content

← See all Allergy brands

Allergy by Accudial Pharmaceutical, Inc.

Medically reviewed on February 6, 2018

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 12.5mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-161

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Allergy

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Diphenhydramine, USP HCl 12.5 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
  • 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.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)Dose (TSP)
TSP = teaspoon
under 6 yrs.ask a doctor
6 to under 121-2 TSP
or as directed by a doctor

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Other information
  • each teaspoon contains: sodium 7 mg
  • store between 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions
  • may be given every 4 to 6 hours
  • do not use more than 6 times in 24 hours
  • use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Questions?

877-434-2036

Inactive ingredients

artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.

Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCUDIAL®

Children's
Allergy

Diphenhydramine HCl
Oral Solution Antihistamine

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

Earth-Friendly
Package!

For Ages 6 yrs to under 12 yrs

Tamper Evident

Compares to Children's
Benadryl® Allergy

Dye-Free
BUBBLEGUM
FLAVOR

NDC 45014-161-04
4 FL. OZ. (118 mL)

ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-161
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid 
Sodium 
Glycerin 
Polysorbate 20 
Propylene Glycol 
Water 
Sodium Benzoate 
Saccharin Sodium 
Trisodium Citrate Dihydrate 
Sorbitol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-161-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/2013
Labeler - Accudial Pharmaceutical, Inc. (831999201)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546ANALYSIS(45014-161), MANUFACTURE(45014-161), RELABEL(45014-161), REPACK(45014-161)

 
Accudial Pharmaceutical, Inc.

← See all Allergy brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide