SELECT HEALTH ALLERGY RELIEF- diphenhydramine hydrochloride liquid

Select Health Allergy Relief by

Drug Labeling and Warnings

Select Health Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Axcentria Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL tsp)

Diphenhydramine 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

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

• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• take every 4 to 6 hours
• do not take more than 6 doses in 24 hours
• children under 2 years: do not use
• children 2 to 5 years: do not use unless directed by a doctor
• children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)

Other Information

• each teaspoon contains: sodium 14 mg
• store between 20 to 25°C (68 to 77°F)
• protect from light
• store in outer carton until contents sused.

Inactive Ingredients

anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions?

Adverse drug event call (888) 933-3222

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton

Children's
ALLERGY
RELIEF

HealthSelect®

Diphenhydramine HCl
Antihistamine

For Temporary Relief of:

• Itchy, Watery Eyes
• Itchy Throat
• Runny Nose
• Sneezing

For Ages 12 and Older
Alcohol Free

NET 4 FL OZ
(118 ML)

NDC: 49743-3001-1

INGREDIENTS AND APPEARANCE

SELECT HEALTH ALLERGY RELIEF   CHERRY
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49743-3003
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)
Sodium Benzoate (UNII: OJ245FE5EU)
Glycerin (UNII: PDC6A3C0OX)
polyethylene glycols (UNII: 3WJQ0SDW1A)
sodium citrate (UNII: 1Q73Q2JULR)
sodium chloride (UNII: 451W47IQ8X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49743-3003-1	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/01/2011

Labeler - Axcentria Pharmaceuticals, LLC. (961871501)

Establishment
Name	Address	ID/FEI	Business Operations
Axcentria Pharmaceuticals, LLC.		961871501	MANUFACTURE