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
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.
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 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 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)