Label: LORATADINE- loratadine tablet
- NDC Code(s): 21130-526-13, 21130-526-31, 21130-526-43, 21130-526-69
- Packager: SAFEWAY 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° to 25° C (68° to 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-526 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 RX526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-526-69 1 in 1 CARTON 1 10 in 1 BLISTER PACK 2 NDC:21130-526-31 3 in 1 CARTON 2 10 in 1 BLISTER PACK 3 NDC:21130-526-43 1 in 1 CARTON 3 45 in 1 BOTTLE 4 NDC:21130-526-13 1 in 1 CARTON 4 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076134 06/06/2009 Labeler - SAFEWAY INC. (009137209) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 051565745 manufacture(21130-526)