Loratadine: Package Insert and Label Information

LORATADINE- loratadine tablet
A-S Medication Solutions

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: 50090-4316

NDC: 50090-4316-0 30 TABLET in a BOTTLE

LORATADINE TABLET

Label Image
(click image for full-size original)
LORATADINE
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4316(NDC:16714-898)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code L612
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4316-0 30 TABLET in 1 BOTTLE None
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 Operations
A-S Medication Solutions 830016429 RELABEL (50090-4316), REPACK (50090-4316)

Revised: 09/2021 A-S Medication Solutions

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