NDC | 66715-6850-0 |
Set ID | b751fa07-816f-4861-bf10-5adb4afc9a89 |
Category | HUMAN OTC DRUG LABEL |
Packager | Lil' Drug Store Products, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA078780 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
- 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- Directions
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
lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide
Close - Questions or comments?
- PRINCIPAL DISPLAY PANEL - 5 Tablet Carton
QUALITY
GUARANTEEDCompare to the Active
Ingredient in Zyrtec®*24 Hour
Allergy
Indoor & OutdoorCetirizine HCl Tablets, 10 mg
AntihistamineRelieves
• Runny Nose • Sneezing
• Itchy, Watery Eyes
• Itchy Nose or ThroatACTUAL SIZE
5
TabletsLil'
Drug Store® - INGREDIENTS AND APPEARANCE
24 HOUR ALLERGY LIL DRUG STORE PRODUCTS
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6850 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 Glycols (UNII: 3WJQ0SDW1A) Polyvinyl alcohol (UNII: 532B59J990) povidones (UNII: FZ989GH94E) Starch, Corn (UNII: O8232NY3SJ) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 8mm Flavor Imprint Code IP46 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6850-0 1 in 1 CARTON 1 5 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 ANDA078780 11/01/2014 Labeler - Lil' Drug Store Products, Inc (093103646)