Label: LORATADINE- loratadine tablet
- NDC Code(s): 53329-651-33, 53329-651-38
- Packager: Medline Industries, 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)
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
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
- store between 20 and 25° C (68 and 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-651 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) Product Characteristics Color white (White to Off-White) Score no score Shape ROUND Size 6mm Flavor Imprint Code RX526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-651-33 30 in 1 BOTTLE 2 NDC:53329-651-38 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 08/19/2003 Labeler - Medline Industries, Inc. (025460908) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(53329-651)