ALLERGY- diphenhydramine hydrochloride liquid

Allergy by

Drug Labeling and Warnings

Allergy by is a Otc medication manufactured, distributed, or labeled by Accudial Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

ALLERGY 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Citric Acid Monohydrate (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 20 (UNII: 7T1F30V5YH)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

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

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)