Label: LORATADINE- loratadine tablet
- NDC Code(s): 0378-8880-10
- Packager: Mylan Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 15, 2013
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- Active ingredient
(in each tablet)
Loratadine USP, 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
- Do not use
if you have ever had an allergic reaction to this product or any of its ingredients.Close
- Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.Close
- When using this product
do not take more than directed. Taking more than directed may cause drowsiness.Close
- Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.Close
- If pregnant or breast-feeding,
ask a health professional before use.Close
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
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 of kidney disease
ask a doctor
- Other information
- Tamper Evident: do not use if foil seal under cap is missing, open or broken.
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
- Inactive ingredients
Corn starch, lactose monohydrate and magnesium stearate.Close
- Questions or comments?
call 1-877-446-3679 (1-877-4-INFO-RX)
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in IndiaClose
Code No.: MH/DRUGS/25/NKD/89
- PRINCIPAL DISPLAY PANEL
Original Prescription Strength
Tablets USP, 10 mg
Indoor and Outdoor Allergies
24 Hour Relief of:
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0378-8880 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code G;L;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0378-8880-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076154 06/01/2011 Labeler - Mylan Pharmaceuticals Inc. (059295980)