ALLERGY- diphenhydramine hydrochloride liquid

Allergy by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• 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.

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 12	1-2 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

• each teaspoon contains: sodium 7 mg
• store between 20°-25°C (68°-77°F)
• tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions

• may be given every 4 to 6 hours
• do not use more than 6 times in 24 hours
• use only enclosed dosing cup to dose this product. Do not use any other dosing device.

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

ALLERGY 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-161
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
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
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45014-161-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/01/2013

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Pharm, Inc.		801652546	ANALYSIS(45014-161) , MANUFACTURE(45014-161) , RELABEL(45014-161) , REPACK(45014-161)