Label: LORATADINE ANTIHISTAMINE- loratadine tablet
- NDC Code(s): 50436-3502-1
- Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 45802-650
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 1, 2017
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Loratadine 10 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
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)
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 starchClose
- Questions or comments?
- HOW SUPPLIED
NDC: 50436-3502-1 30 TABLET in a BOTTLEClose
- LORATADINE ANTIHISTAMINE (LORATADINE) TABLET
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-3502(NDC:45802-650) 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:50436-3502-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/15/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 10/15/2008 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-3502) , RELABEL(50436-3502)