Label: CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)- cetirizine hydrochloride tablet
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NDC Code(s):
58602-446-09,
58602-446-17,
58602-446-21,
58602-446-41, view more58602-446-47, 58602-447-09, 58602-447-17, 58602-447-21, 58602-447-41, 58602-447-47, 58602-813-04, 58602-813-09, 58602-813-17, 58602-813-23, 58602-813-39, 58602-813-41, 58602-813-83, 58602-813-99
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- 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 a 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 any of its ingredients or to an antihistamine containing hydroxyzine.
- to prevent hives from any known cause such as:
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children.
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Directions
For 5 mg:
adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over
1 tablet once a day; do not take 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
For 10 mg:
adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-446 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code X;35 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-446-09 1 in 1 CARTON 08/05/2015 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-446-17 1 in 1 CARTON 08/05/2015 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-446-47 75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 08/05/2015 4 NDC:58602-446-41 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2015 5 NDC:58602-446-21 10 in 1 CARTON 08/05/2015 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 08/05/2015 CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-447 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code X;36 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-447-09 1 in 1 CARTON 08/05/2015 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-447-17 1 in 1 CARTON 08/05/2015 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-447-47 75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 08/05/2015 4 NDC:58602-447-41 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2015 5 NDC:58602-447-21 10 in 1 CARTON 08/05/2015 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 08/05/2015 CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-813 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to Off-white) Score 2 pieces Shape RECTANGLE (off-rectangular) Size 9mm Flavor Imprint Code X;2;0 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-813-09 1 in 1 CARTON 08/05/2015 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-813-17 1 in 1 CARTON 08/05/2015 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-813-99 75 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 08/05/2015 4 NDC:58602-813-23 1 in 1 CARTON 08/05/2015 4 120 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:58602-813-39 1 in 1 CARTON 08/05/2015 5 365 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:58602-813-41 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2015 7 NDC:58602-813-04 10 in 1 CARTON; Type 0: Not a Combination Product 08/05/2015 8 NDC:58602-813-83 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/05/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 08/05/2015 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 918917642 ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)