LORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LORATADINE- LORATADINE TABLET
CARDINAL HEALTH 107, LLC
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MAJOR PHARMACEUTICALS ALLERGY DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Loratadine 10 mg
Original Prescription Strength
PURPOSE
Antihistamine
USES
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
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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-
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
800-222-1222)
This unit dose package is not child resistant and is Intended for
Institutional Use Only.
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
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INACTIVE INGREDIENTS
lactose monohydrate, magnesium stearate, povidone, pregelatinized
starch
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152 USA
DISTRIBUTED BY:
CARDINAL HEALTH
Dublin, OH 43017
L5534946-11223
L5534946-21223
PRINCIPAL DISPLAY PANEL
Loratadine Tablets
10 mg
Original Prescription Strength
Antihistamine
10 Tablets
do not use if printed foil under cap is broken or missing
store between 20 to 25 C (68 to 77 F)
°
°
°
°
Gluten Free
LORATADINE
loratadine tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55154-8082(NDC:0904-6852)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF