Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 66336-560-14, 66336-560-30 - Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-425
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 3, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
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Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you havekidney disease. Your doctor should determine if you need a different dose.
When using this product- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding,ask a health professional before use.
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
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Package/Label Principal Display Panel
NDC 66336-0560-XX
NDC 66336-0560-14
NDC 66336-0560-30
Compare to Allegra® Allergy active ingredient
Fexofenadine Hydrochloride Tablets, 60 mg
Antihistamine
Non-Drowsy
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
Original Prescription Strength
12 Hour
60 mg Each
Actual Size
Indoor and Outdoor Allergies
Allergy
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66336-560(NDC:45802-425) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (Peach) Score no score Shape ROUND Size 8mm Flavor Imprint Code 93;7252 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66336-560-14 14 in 1 BOTTLE 2 NDC:66336-560-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 08/08/2011 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel, repack