Label: CETIRIZINE HYDROCHLORIDE tablet
-
NDC Code(s):
71205-207-06,
71205-207-10,
71205-207-15,
71205-207-30, view more71205-207-60, 71205-207-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 45802-919
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 1, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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.
When using this product
- 1.
- drowsiness may occur
- 2.
- avoid alcoholic drinks
- 3.
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 4.
- 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
- Questions or comments?
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Principal Display Panel
Compare to Zyrtec® active ingredient
Cetirizine Hydrochloride Tablets 10 mg
Antihistamine
Allergy
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Original Prescription Strength
actual size
30 Tablets
Indoor & Outdoor Allergies
NDC 71205-207-30
Repackaged By:
Proficient Rx LP
Thousand Oaks, CA 91320
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-207(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) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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:71205-207-06 6 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2019 2 NDC:71205-207-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2019 3 NDC:71205-207-15 15 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2019 4 NDC:71205-207-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 5 NDC:71205-207-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 6 NDC:71205-207-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078336 12/27/2007 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-207) , RELABEL(71205-207)