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Allergy

Accudial Pharmaceutical, Inc.

CHILDREN'S ACCUDIAL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ALLERGY

Drug Facts

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine

Allergy 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)

Allergy 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

Allergy

Diphenhydramine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label 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 12.5 mg

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45014-140-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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