Label: CETIRIZINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67046-680-30 - Packager: Contract Pharmacy Services-PA
- This is a repackaged label.
- Source NDC Code(s): 45802-919
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 22, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
Cetirizine 10mg 680
"These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"DOSAGE AND ADMINISTRATION
adults and children 6 years and over (4)
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. (4)
adults 65 years and over (4)
ask a doctor (4)
children under 6 years of age (4)
ask a doctor (4)
consumers with liver or kidney disease (4)
ask a doctor (4)
INDICATIONS AND USAGE
Revised: 2/2018
- Table of Contents
- ACTIVE INGREDIENT
- PURPOSE
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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.
Ask a doctor or pharmacist before use if you are
taking tranquilizers or sedatives.
When using this product
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drowsiness may occur
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avoid alcoholic drinks
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alcohol, sedatives, and tranquilizers may increase drowsiness
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be careful when driving a motor vehicle or operating machineryStop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding:
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if breast-feeding: not recommended
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if pregnant: ask a health professional before use.Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE
cetirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67046-680(NDC:45802-919) 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) Product Characteristics Color white Score no score Shape OVAL Size 10mm Flavor Imprint Code 4H2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67046-680-30 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078336 02/14/2018 Labeler - Contract Pharmacy Services-PA (945429777) Establishment Name Address ID/FEI Business Operations Coupler Enterprises Inc. 945429777 repack(67046-680)
