Label: ALLERGY RELIEF- cetirizine hcl tablet
- NDC Code(s): 70677-1047-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 30, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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
- 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.
-
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?
-
Principal Display Panel
COMPARE TO ZYRTEC® ACTIVE INGREDIENT*
ORIGINAL PRESCRIPTION STRENGTH
All Day Allergy
Cetirizine HCl 10 mg
ANTIHISTAMINE
Gluten Free
Indoor % Outdoor Allergies
24-Hour symptom relief
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
TABLETS
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, distributor of Zyrtec®.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by: McKesson Corp., via Strategic
Sourcing Services LLC. Memphis, TN 38141
www.fosterandthrive.com
- Package Labeling
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
cetirizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1047 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) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score 2 pieces Shape OVAL Size 9mm Flavor Imprint Code G4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1047-1 14 in 1 CARTON 03/01/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 03/01/2023 Labeler - Strategic Sourcing Services LLC (116956644)