Label: CETIRIZINE HYDROCHLORIDE tablet
-
NDC Code(s):
70985-002-01,
70985-002-02,
70985-002-03,
70985-002-04, view more70985-002-05
- Packager: Drug Ocean LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 22, 2023
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.
-
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
- Other Information
- Inactive Ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
DRUG OCEAN NDC 70985-002-01
Original Prescription Strength
Cetirizine Hydrochloride
Tablets USP10 mg
6 yrs& older
100 Tablets
DRUG OCEAN NDC 70985-002-02
Original Prescription Strength
Cetirizine Hydrochloride
Tablets USP10 mg
6 yrs& older
500 Tablets
DRUG OCEAN NDC 70985-002-03
Original Prescription Strength
Cetirizine Hydrochloride
Tablets USP10 mg
6 yrs& older
30 Tablets
DRUG OCEAN NDC 70985-002-04
Original Prescription Strength
Cetirizine Hydrochloride
Tablets USP10 mg
6 yrs& older
90 Tablets
DRUG OCEAN NDC 70985-002-05
Original Prescription Strength
Cetirizine Hydrochloride
Tablets USP10 mg
6 yrs& older
300 Tablets
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70985-002 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 (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) 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:70985-002-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/08/2016 2 NDC:70985-002-02 500 in 1 BOTTLE; Type 0: Not a Combination Product 11/08/2016 3 NDC:70985-002-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 4 NDC:70985-002-04 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 5 NDC:70985-002-05 300 in 1 BOTTLE; Type 0: Not a Combination Product 08/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 11/08/2016 Labeler - Drug Ocean LLC (080381835) Registrant - Unique Pharmaceutical Laboratories (917165052) Establishment Name Address ID/FEI Business Operations Unique Pharmaceutical Laboratories 650434645 manufacture(70985-002)