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Name:Allergy
Manufacturer:Accudial Pharmaceutical, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


CHILDREN'S ACCUDIAL

ALLERGY - diphenhydramine hydrochloride liquid 
Accudial Pharmaceutical, Inc.


1
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.

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CHILDREN'S
ACCUDIAL

ALLERGY

Drug Facts

Active ingredient (in each 5 mL)1

Diphenhydramine HCl 12.5 mg


1
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 years do not use
children 2 to 5 years do not use unless directed by a doctor
children 6 to under 12 years 5 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

Principal Display Panel - 118 mL Carton


ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-140
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 12.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color PINK Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45014-140-04 118 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/26/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Revised: 11/2009 Accudial Pharmaceutical, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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