Label: LORATADINE- loratadine tablet
- NDC Code(s): 61919-142-10, 61919-142-30
- Packager: DIRECT RX
- 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nosesneezing
- itchy, watery eyes
- itching of the nose or throat
- ACTIVE INGREDIENT IN EACH TABLET
Loratadine 10 mgClose
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.Close
- DOSAGE & ADMINISTRATION
- do not use if printed foil under cap is broken or missing
- store at 20°-25°C (68°-77°F)
Questions or comments?
- INACTIVE INGREDIENTS
lactose monohydrate, magnesium stearate, povidone, pregelatinized starchClose
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
Compare to Claritin® active ingredient
Loratadine Tablets, 10 mg
Itchy, Watery Eyes
Itchy Throat or Nose
Indoor & Outdoor Allergies
*When taken as directed. See Drug Facts Panel.
10mg Label Image:
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61919-142(NDC:45802-650) Route of Administration ORAL DEA Schedule 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) STARCH, CORN (UNII: O8232NY3SJ) 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:61919-142-10 10 in 1 BOTTLE 1 NDC:61919-142-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-142) , relabel(61919-142)