Label: CETIRIZINE HYDROCHLORIDE HIVES RELIEF- cetirizine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 65162-146-03, 65162-146-50 - Packager: Amneal Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 21, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
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WARNINGS
Severe Allergy Warning: Get emergency help immediately if you have hives along
with any of the following symptoms:
• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
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DO NOT USE
Do not use
• to prevent hives from any known cause such as:
• foods • insect stings • medicines • latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for medical exam. Your doctor may be able to help you find a cause.
• if you have ever had an allergic reaction to this product or its ingredients or to an antihistamine containing hydroxyzine.
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE AND ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-146 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code IP;46 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-146-03 1 in 1 CARTON 1 30 in 1 BOTTLE 2 NDC:65162-146-50 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078780 01/21/2010 Labeler - Amneal Pharmaceuticals (123797875) Registrant - Amneal Pharmaceuticals (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals 831227801 ANALYSIS, LABEL, MANUFACTURE, PACK