Label: LORATADINE- loratadine tablet
- NDC Code(s): 0378-8880-10, 0378-8880-93
- Packager: Mylan Pharmaceuticals Inc.
- 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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- 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 LABEL Item Code (Source) NDC:0378-8880 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE 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:0378-8880-93 30 in 1 BOTTLE, PLASTIC 2 NDC:0378-8880-10 1000 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076154 03/27/2013 Labeler - Mylan Pharmaceuticals Inc. (059295980)