Label: FEXOFENADINE HYDROCHLORIDE - fexofenadine hydrochloride tablet, film coated
- NDC Code(s): 60760-104-30
- Packager: St Marys Medical Park Pharmacy
- This is a repackaged label.
- Source NDC Code(s): 45802-571
- 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)
Fexofenadine HCl 180 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
Ask a doctor before use if you have
kidney 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)
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
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 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
- Other information
- do not use if printed foil under cap is broken or missing
- store at 20°-25°C (68°-77°F)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 3
- Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxideClose
- Questions or comments?
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
fexofenadine hydrochloride tablet, film coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60760-104(NDC:45802-571) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONE TITANIUM DIOXIDE FERRIC OXIDE RED Product Characteristics Color ORANGE (peach) Score no score Shape ROUND Size 12mm Flavor Imprint Code 93;7253 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60760-104-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 01/10/2013 Labeler - St Marys Medical Park Pharmacy (063050751) Establishment Name Address ID/FEI Business Operations St Marys Medical Park Pharmacy 063050751 relabel(60760-104), repack(60760-104) Establishment Name Address ID/FEI Business Operations Teva Pharmaceutical Industries Ltd. 533065798 manufacture(60760-104)