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Allergy by Accudial Pharmaceutical, Inc.

Dosage form: liquid
Ingredients: Diphenhydramine Hydrochloride 12.5mg in 5mL
Labeler: Accudial Pharmaceutical, Inc.
NDC Code: 45014-140


5mL = one teaspoon

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.

CHILDREN'S
ACCUDIAL

ALLERGY

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg


5mL = one teaspoon

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

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

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
children under 2 yearsdo not use
children 2 to 5 yearsdo not use unless directed by a doctor
children 6 to under 12 years5 mL to 10 mL
(1 to 2 teaspoonfuls)

Other information

each teaspoon contains:

  • sodium 3 mg
  • store between 20°-25°C (68°-79°F). Protect from light. Store in outer carton until contents used.

Inactive ingredients

artificial flavor, citric acid, D&C red no. 33, FD&C red no. 40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING
BY WEIGHT

Diphenhydramine HCl
Oral Solution
Anthistamine

FOR RELIEF OF
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat

For Ages 6 to under 12

Alcohol & Sugar Free
Compares to Children's
Benadryl® Allergy.

CHERRY
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-140-04

Allergy

ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-140
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
Citric Acid Monohydrate 
D&C RED NO. 33 
FD&C RED NO. 40 
Glycerin 
Polysorbate 20 
Water 
Sodium Benzoate 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:45014-140-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/26/2009
Labeler - Accudial Pharmaceutical, Inc. (831999201)

 
Accudial Pharmaceutical, Inc.

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Medically reviewed on Nov 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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