Label: ALLERGY RELIEF- cetirizine hydrochloride tablet, coated
- NDC Code(s): 83324-091-14, 83324-091-30, 83324-091-90
- Packager: CHAIN DRUG MARKETING ASSOCIATION, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 16, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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WARNINGS
Warnings
Do not useif 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 haveliver 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.
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Directions
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
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PRINCIPAL DISPLAY PANEL
QUALITY CHOICE®
NDC 83324-091-14
†Compare to Active ingredient in ZYRTEC® Allergy
Original Prescription Strength
Allergy Relief
24 Hour
Cetirizine Hydrochloride Tablets, 10 mg
Antihistamine
Indoor & Outdoor Allergies
For Relief of: Sneezing | Runny Nose | Itchy, Watery Eyes | Itchy Throat or Nose
Actual Size
14 TABLETS
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
cetirizine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83324-091 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) Product Characteristics Color white (white to off white) Score 2 pieces Shape RECTANGLE (rounded off rectangualr) Size 9mm Flavor Imprint Code G;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83324-091-14 1 in 1 CARTON 08/16/2024 1 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:83324-091-30 1 in 1 CARTON 08/16/2024 2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:83324-091-90 1 in 1 CARTON 08/17/2024 3 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 08/16/2024 Labeler - CHAIN DRUG MARKETING ASSOCIATION, INC. (011920774)