Label: CETIRIZINE HYDROCHLORIDE tablet
- NDC Code(s): 70934-199-30, 70934-199-90, 70934-199-97
- Packager: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 16571-402
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 3, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT
- STOP USE
- IF PREGNANT OR BREAST FEEDING:
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
Adults and children 6
years and overone 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?
- SPL UNCLASSIFIED SECTION
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70934-199(NDC:16571-402) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (White) Score no score Shape BULLET (Barrel Shaped) Size 8mm Flavor Imprint Code CTN;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70934-199-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/04/2018 09/30/2024 2 NDC:70934-199-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/29/2019 03/31/2024 3 NDC:70934-199-97 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/29/2019 10/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 12/04/2018 09/30/2024 Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546) Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546) Establishment Name Address ID/FEI Business Operations Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack(70934-199)