Label: REXALL ALLERGY RELIEF NON DROWSY- loratadine tablet
- NDC Code(s): 55910-612-65
- Packager: Dolgencorp, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 22, 2010
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- 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.
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 at 20°-25°C (68°-77°F)
- Inactive ingredients
lactose monohydrate, magnesium stearate, povidone, pregelatinized starchClose
- Principal Display Panel
Loratadine Tablets, 10 mg/Antihistamine
Itchy, watery eyes
Itchy throat or nose
Original Prescription Strength
Indoor & outdoor allergies
*When taken as directed.
See Drug Facts Panel.
Allergy Relief Carton Image 1
Allergy Relief Carton Image 2
- INGREDIENTS AND APPEARANCE
REXALL ALLERGY RELIEF NON DROWSY
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-612 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 (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:55910-612-65 1 in 1 CARTON 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 08/22/2010 Labeler - Dolgencorp, LLC (068331990)