Label: LORATADINE- loratadine tablet
- NDC Code(s): 55154-5099-0
- Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 51079-538
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 18, 2013
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Original Prescription Strength
Indoor and Outdoor Allergies
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.Close
- 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
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.
- Directions (24 Hour Relief)
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
- TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
- Inactive ingredients
Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.Close
- Questions or comments?
- Serious side effects associated with use of this product may be reported to this number.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
UDL Laboratories, Inc.
Rockford, IL 61103
- Principal Display Panel
Loratadine Tablets, USP
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5099(NDC:51079-538) 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 7mm Flavor Imprint Code M;L;17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-5099-0 10 in 1 BAG 1 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075790 11/19/2009 Labeler - Cardinal Health (188557102) Establishment Name Address ID/FEI Business Operations Cardinal Health 188557102 REPACK(55154-5099)