Label: CETIRIZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55700-331-30 - Packager: Lake Erie Medical DBA Quality Care Products LLC
- This is a repackaged label.
- Source NDC Code(s): 16571-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 18, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- PURPOSE
- Warnings
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- When using this product
- STOP USE
- If pregnant or breast-feeding:
- Keep out of reach of children.
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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 sever 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
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55700-331(NDC:16571-401) 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 hypromelloses (UNII: 3NXW29V3WO) lactose (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) starch, corn (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white (White) Score no score Shape BULLET (Barrel Shaped) Size 7mm Flavor Imprint Code CTN;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55700-331-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758) Establishment Name Address ID/FEI Business Operations Lake Erie Medical DBA Quality Care Products LLC 831276758 repack(55700-331)