Label: LEADER ALL DAY ALLERGY- cetirizine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-820-65, 37205-820-70, 37205-820-74, 37205-820-75, view more37205-820-76 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 27, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
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WARNINGS
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
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
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
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PRINCIPAL DISPLAY PANEL
Compare to Zyrtec® active ingredient†
ORIGINAL PRESCRIPTION STRENGTH
Cetirizine HCl Tablets, 10 mg/Antihistamine
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
†This product is not manufactured or distributed by McNeil-PPC, Inc.,distributor ofZyrtec®. Zyrtec®is a registered trademark of UCB Pharma, S.A.
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INGREDIENTS AND APPEARANCE
LEADER ALL DAY ALLERGY
cetirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-820 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color white Score no score Shape RECTANGLE (rounded-off) Size 9mm Flavor Imprint Code RI52 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-820-74 14 in 1 BLISTER PACK 2 NDC:37205-820-65 30 in 1 BOTTLE 3 NDC:37205-820-70 45 in 1 BOTTLE 4 NDC:37205-820-75 90 in 1 BOTTLE 5 NDC:37205-820-76 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077498 12/27/2007 Labeler - Cardinal Health (097537435) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(37205-820)