Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet
- NDC Code(s): 53329-652-38
- Packager: Medline Industries, 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)
- runny nose
- itchy, watery eyes
- itching of the nose or throat
Do not use
Ask a doctor before use if you have
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
If pregnant or breast-feeding
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep out of reach of children.
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
- store between 20° to 25° C (68° to 77° F)
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
cetirizine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-652 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) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape RECTANGLE (Rounded Off) Size 9mm Flavor Imprint Code R152 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-652-38 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077498 12/27/2007 Labeler - Medline Industries, Inc. (025460908) Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) Establishment Name Address ID/FEI Business Operations Ohm Laboratories Inc. 184769029 manufacture(53329-652)