Loratadineantihistamineantihistamine tablet

Otc - active ingredient

Loratadine 10 mg

Otc - purpose

Antihistamine

Indications & usage

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

if you have ever had an allergic reaction to this product or any of its ingredients

liver or kidney disease. Your doctor should determine if you need a different dose.

do not take more than directed. Taking more than directed may cause drowsiness.

an allergic reaction to this product occurs. Seek medical help right away.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Dosage & administration

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

Storage and handling

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

Inactive ingredient

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Otc - questions

1-800-719-9260

Otc - keep out of reach of children

Ingredients and appearance - Product information

Loratadineantihistamineantihistamine tablet- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52125-600
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidones ( UNII: FZ989GH94E)

Product Characteristics

Color white Score 1
Shape OVAL (TABLET) Imprint Code L612
Size 8 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 52125-600-14 2 in 1 BOTTLE 2015/04/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076301 USA 2015/04/02

Labeler - REMEDYREPACK INC.( 829572556)

Package label.principal display panel section

DRUG: Loratadineantihistamine antihistamine


GENERIC: Loratadine


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 52125-600-14


ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1


INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POVIDONES


COLOR: white


SHAPE: OVAL


SCORE: No score


SIZE: 8 mm


IMPRINT: L612


PACKAGING: 2 in 1 BOTTLE