LORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Spirit Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: -  runny nose -  sneezing - itchy, water eyes  -  itching of the nose or throat you have liver or kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LORATADINE- LORATADINE TABLET
SPIRIT PHARMACEUTICALS LLC
----------
LORATADINE TABLETS, 10 MG
_ACTIVE INGREDIENT_
Loratadine 10 mg
_PURPOSE_
Antihistamine
_USES_
temporarily relieves these symptoms due to hay fever or other upper
respiratory
allergies:
runny nose
sneezing
itchy, water 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 USUNG 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.
_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 diseaseask a doctor
_OTHER INFORMATION_
Tamper-evident: do not use if foil under cap is missing, open or
broken
store between 20º to 25ºC (68º to 77ºF)
_INACTIVE INGREDIENTS_
Lactose monohydrate, magnesium stearate, sodium starch glycolate and
starch maize
pregelatinized
_QUESTIONS OR COMMENTS? _
1-888-333-9792
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Claritin®†
NON-DROWSY*
Original Prescription Strength
Loratadine Tablets, 10 mg / Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes
• Itchy Throat or Nose
365 Tablets
*When taken as directed
See Drug Facts Panel
†This product is not manufactured or distributed by Bayer
Healthcare, LLC, owner of the
registered trademark Claritin®.
LORATADINE
loratadine tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:68210-4110
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIE