Label: FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI tablet, extended release
Contains inactivated NDC Code(s)
NDC Code(s): 21130-557-35
- Packager: Safeway Inc
- This is a repackaged label.
- Source NDC Code(s): 55111-557
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 4, 2014
If you are a consumer or patient please visit this version.
- Active ingredient(s)
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- nasal congestion
- itchy, watery eyes
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Do not use
- if you have ever had an allergic reaction to this product or any of its ingredients
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have difficulty swallowing
Ask a doctor before use if
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- 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)
- the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).
Stop use and ask doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- symptoms do not improve within 7 days or are accompanied by a fever
- you get nervous, dizzy, or sleepless
- do not divide, crush, chew or dissolve the tablet; swallow tablet whole
adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; 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
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
fexofenadine hcl and pseudoephedrine hci tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-557(NDC:55111-557) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg Inactive Ingredients Ingredient Name Strength ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) COPOVIDONE (UNII: D9C330MD8B) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code RDY;572 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-557-35 2 in 1 CARTON 1 5 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079043 02/05/2013 Labeler - Safeway Inc (009137209)