ALLERGY RELIEF NON DROWSY- loratadine tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Loratadine, USP 10 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

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product,

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

 an allergic reaction to this product occurs. Seek medical help right away

If pregnant or breast-feeding,

 ask a health professional before use.

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

• adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours
• children under 6 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

Product: 50090-4148

NDC: 50090-4148-0 10 TABLET in a BOTTLE

NDC: 50090-4148-4 30 TABLET in a BOTTLE, PLASTIC

NDC: 50090-4148-5 90 TABLET in a BOTTLE, PLASTIC

Storage

Distributed by: Camber Consumer Care Inc., Piscataway, NJ 08854, USA

Loratadine

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF  NON DROWSY
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-4148(NDC:69230-312)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	GG296
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-4148-0	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2019
2	NDC: 50090-4148-4	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2018
3	NDC: 50090-4148-5	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075209	12/31/2018

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-4148) , REPACK(50090-4148)