Label: CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)- cetirizine hydrochloride capsule
- NDC Code(s): 58602-808-04, 58602-808-12, 58602-808-16, 58602-808-53
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 14, 2020
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 capsule)
- Purpose
- Uses
-
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 occuring. 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 DOCTOR/PHARMACIST
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children.
-
Directions
adults and children
6 years and over
one 10 mg capsule once daily;
do not take more than one 10 mg
capsule 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 or comments?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Carton Label)
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)
cetirizine hydrochloride capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-808 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) Product Characteristics Color YELLOW (Clear colourless to pale yellow viscous liquid) Score no score Shape OVAL Size 13mm Flavor Imprint Code CZ10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-808-04 1 in 1 CARTON 07/20/2018 1 12 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58602-808-53 1 in 1 CARTON 07/20/2018 2 25 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58602-808-12 1 in 1 CARTON 07/20/2018 3 40 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58602-808-16 65 in 1 CARTON 07/20/2018 4 65 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209107 07/20/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-808) , MANUFACTURE(58602-808) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(58602-808) , MANUFACTURE(58602-808)
