ALLERGY- diphenhydramine hydrochloride liquid 
Accudial Pharmaceutical, Inc.

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.

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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:

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

Directions

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)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-161
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Sodium (UNII: 9NEZ333N27)  
Glycerin (UNII: PDC6A3C0OX)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Trisodium Citrate Dihydrate (UNII: B22547B95K)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Bio-Pharm, Inc.801652546ANALYSIS(45014-161) , MANUFACTURE(45014-161) , RELABEL(45014-161) , REPACK(45014-161)

Revised: 2/2013
Document Id: f8c91261-b067-4bea-810b-6b28dc893b0e
Set id: cb18f535-1876-4d1b-962a-a9fde8f180bb
Version: 1
Effective Time: 20130206
 
Accudial Pharmaceutical, Inc.