Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet
- NDC Code(s): 0536-4088-07, 0536-4088-11, 0536-4088-88
- Packager: Rugby Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredient (in each tablet)
Cetirizine HCl 10 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
● runny nose
● itchy, watery eyes
● itching of the nose or throatClose
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.Close
- Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.Close
- Ask a doctor or pharmacist before use if you are
taking tranquilizers or sedatives.Close
- 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 machineryClose
- Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.Close
- If pregnant or breast-feeding
• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.Close
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
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
• store between 20 to 25°C (68 to 77°F)Close
- Inactive Ingredients
lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc, titanium dioxide.Close
- Questions or comments?
Call 1-800-645-2158, 9am-5pm ET. Monday-FridayClose
- Principal Display Panel
Compare to Active Ingredient in ZYRTEC®*
Original Prescription Strength
CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg
Indoor and Outdoor Allergies
24 hour relief of:
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
*Rugby Laboratories is not affiliated with the owner of the trademark Zyrtec®.
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150Close
- Product Label
Rugby Cetirizine 10 mg Allergy Tablet
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4088 Route of Administration ORAL DEA Schedule 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) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:0536-4088-11 4 in 1 BOX 1 90 in 1 BLISTER PACK 2 NDC:0536-4088-88 1 in 1 BOX 2 14 in 1 BLISTER PACK 3 NDC:0536-4088-07 2 in 1 BOX 3 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078780 03/23/2012 Labeler - Rugby Laboratories Inc (191427277) Registrant - P and L Development of New York Corporation (800014821)