Label: SHOPRITE ALLERGY- cetirizine hydrochloride tablet
- NDC Code(s): 41190-458-66, 41190-458-72
- Packager: Wakefern Food Corporation
- 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.
If you are a consumer or patient please visit this version.
- 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 throat
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.
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. (1-800-222-1222)
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
- do not use if blister unit is broken or torn
- store between 20° to 25°C (68° to 77°F)
- Inactive ingredients
corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetinClose
- Questions or comments?
- Principal Display Panel
Compare to: Active Ingredient in Zyrtec®
ORIGINAL PRESCRIPTION STRENGTH
Cetirizine Hydrochloride Tablets, 10 mg – Antihistamine
INDOOR & OUTDOOR ALLERGIES
24 Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose
- INGREDIENTS AND APPEARANCE
cetirizine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41190-458 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code 4H2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41190-458-66 1 in 1 CARTON 1 14 in 1 BLISTER PACK 2 NDC:41190-458-72 1 in 1 CARTON 2 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078336 08/14/2013 Labeler - Wakefern Food Corporation (069722418)