Label: ALL DAY ALLERGY RELIEF- cetirizine hcl tablet
- NDC Code(s): 59726-129-03, 59726-129-05, 59726-129-14
- Packager: P & L Development, LLC
- This is a repackaged label.
- Source NDC Code(s): 65162-046
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 9, 2021
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use
adults and children 6 years and over Take 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 the active ingredient in Zyrtec®†
cetirizine HCl tablets 10 mg
24 hour relief of:
- itchy, watery eyes
- runny nose
- itchy throat or nose
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Zyrtec®.
200 Hicks Street
Westbury, NY 11590
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
- Package Labeling
INGREDIENTS AND APPEARANCE
ALL DAY ALLERGY RELIEF
cetirizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-129(NDC:65162-046) 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) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color white (white) Score no score Shape OVAL (oval) Size 8mm Flavor Imprint Code IP;46 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-129-14 1 in 1 CARTON 09/01/2010 1 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59726-129-05 1 in 1 CARTON 09/01/2010 2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:59726-129-03 1 in 1 BOX 09/01/2010 3 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078780 09/01/2010 Labeler - P & L Development, LLC (800014821)