Loratadine by A-S Medication Solutions LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine 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 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• itchy, watery eyes
• sneezing
• 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

• do not use if printed foil under cap is broken or missing
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-206-7821

HOW SUPPLIED

Product: 50090-4300

NDC: 50090-4300-0 10 TABLET in a BOTTLE

NDC: 50090-4300-1 20 TABLET in a BOTTLE

NDC: 50090-4300-3 15 TABLET in a BOTTLE

NDC: 50090-4300-4 30 TABLET in a BOTTLE

NDC: 50090-4300-5 90 TABLET in a BOTTLE

NDC: 50090-4300-6 7 TABLET in a BOTTLE

Loratadine

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-4300(NDC:16714-898)
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)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-4300-0	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
2	NDC: 50090-4300-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
3	NDC: 50090-4300-3	15 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
4	NDC: 50090-4300-4	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
5	NDC: 50090-4300-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019
6	NDC: 50090-4300-6	7 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	02/20/2019

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-4300) , REPACK(50090-4300)