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 (1-800-222-1222) right away.

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)
protect from light

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: 50090-5067

NDC: 50090-5067-5 90 TABLET in a BOTTLE

NDC: 50090-5067-0 10 TABLET in a BOTTLE

NDC: 50090-5067-1 20 TABLET in a BOTTLE

NDC: 50090-5067-3 15 TABLET in a BOTTLE

NDC: 50090-5067-4 30 TABLET in a BOTTLE

NDC: 50090-5067-6 7 TABLET in a BOTTLE

Loratadine

ALLERGY RELIEF NON DROWSY
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-5067(NDC:69230-317)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	439
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-5067-3	15 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
2	NDC:50090-5067-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
3	NDC:50090-5067-0	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
4	NDC:50090-5067-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
5	NDC:50090-5067-6	7 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020
6	NDC:50090-5067-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075209	12/27/2019

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-5067) , REPACK(50090-5067)

Drug Facts